Limiting new fast-food outlets may reduce childhood obesity, reveals research

Planning policies to restrict the number of new fast-food outlets leads to fewer overweight and obese children according to research led by Lancaster University.

Researchers examined the impact of policy in the North East of England where Gateshead Council prevented any existing non-fast-food commercial property from being converted into a hot fast-food takeaway.

The lead authors of the study, published in the journal Obesity, are Dr Huasheng Xiang from Lancaster University Management School and Professor of Health Inequalities Heather Brown from the Faculty of Health and Medicine at Lancaster University.

The researchers used Government collected data that included: children’s weight from the National Child Measurement Programme, Food Hygiene Ratings from the Food Standards Agency, and deprivation and population measures from the Office of National Statistics.

They also assessed Gateshead neighbourhoods with comparable areas across the North East. Across the whole borough they found no significant change in childhood overweight and obesity between Gateshead and the areas of comparison.

However, when they looked at neighbourhood deprivation, they found that, in those areas with the highest proportion of fast-food outlets, the Gateshead neighbourhoods were associated with a statistically significant reduction in the prevalence of childhood overweight and obesity in comparison with corresponding neighbourhoods in the North East.

In sub-group analysis by area level deprivation, they found that those quintiles of deprivation within Gateshead with the highest proportion of fast-food outlets had a statistically significant reduction of 4.80% in the prevalence of childhood overweight and obesity in comparison to comparable neighbourhoods in the North East.

Professor Brown said: “Given that a majority of local authorities in England have implemented planning policies that target hot food takeaways, if these are like Gateshead’s and are suitably robust and restrictive, it is possible that they could contribute to our efforts to reduce childhood overweight and obesity. Furthermore, given that such food establishments are found in greater density in more deprived communities, such policies may help reduce health inequalities.”

Alice Wiseman, Director of Public Health at Gateshead Council and Newcastle Council, said: “Creating environments which support access to healthy affordable food is one of the biggest public health missions of our generation.

“The challenge of healthy weight and access to nutritious food is complex, ever changing, and hard to resolve. There is no silver bullet, and several interventions are needed to create real, impactful, and lasting change.

“It’s great to see, when teams across local government come together with full institutional support, how robust planning policies can chip away at such challenges to facilitate healthier and more resilient communities.”

Reference:

Huasheng Xiang, Louis Goffe, Viviana Albani, Nasima Akhter, Amelia A. Lake, Heather Brown, Planning policies to restrict fast food and inequalities in child weight in England: a quasi-experimental analysis,Obesity, https://doi.org/10.1002/oby.24127.

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Healthy Diet May Lower Prostate Cancer Progression Risk finds JAMA study

Researchers found that a diet close to the Dietary Guidelines for Americans significantly reduces the risk of prostate cancer progression in men diagnosed with grade group (GG) 1 prostate cancer who are on active surveillance. A recent study was published in JAMA Oncology conducted by Zhou Tony and colleagues.

Prostate cancer grade reclassification is a term describing changes in cancer grade after follow-up, indicating that the disease is progressing. This study provides critical information regarding whether diet might alter the severity of cancer and whether healthier patterns of eating might reduce the risk of progression among men under surveillance.

This was a prospective cohort study of 886 men diagnosed with GG1 prostate cancer between January 2005 and February 2017. The participants were 50 years or older and chose active surveillance and completed a validated food frequency questionnaire at enrollment. Their dietary patterns were assessed based on guidelines and the inflammatory potential of diet. The analyses were done from 29 October 2023 through 17 June 2024.

The two primary dietary measurements that were used in this research included the Healthy Eating Index 1999-2000 (HEI), and an energy-adjusted HEI (E-HEI), which measures diet consistency with the Dietary Guidelines for Americans. Two more parameters evaluated were Dietary Inflammatory Index (DII), and the energy-adjusted DII (E-DII).

Competing risk regression models were applied to assess whether baseline HEI, E-HEI, DII, and E-DII scores could predict grade reclassification to GG2 or higher or to GG3 or higher (extreme grade reclassification) at any point in time after follow-up. The analyses controlled for the prognostic factors associated with active surveillance and smoking history to minimize confounding.

After a median of 6.5 years of follow-up, that is an interquartile range of 4.0-9.1 years, the results of this study in their main results were summarized below:

Absolute Reclassification Rates

  • A total of 187 men (21%) experienced grade reclassification to GG2 or higher and 55 men (6%) experienced extreme reclassification to GG3 or higher.

Cumulative Incidence of Grade Reclassification

  • 3 years: 7% (95% CI, 5%-9%)

  • 5 years: 15% (95% CI, 12%-17%)

  • 10 years: 33% (95% CI, 29%-37%)

Cumulative Incidence of Extreme Grade Reclassification:

  • 3 years: 2% (95% CI, 1%-4%)

  • 5 years: 4% (95% CI, 3%-5%)

  • 10 years: 10% (95% CI, 7%-13%)

Higher HEI scores were associated with reduced risk for both types of reclassification:

  • For reclassification to GG2 or higher, the SHR was 0.85 (95% CI, 0.73-0.98) per 1-SD increase in HEI, and 0.86 (95% CI, 0.74-1.00) per 1-SD increase in E-HEI score.

  • For extreme reclassification to GG3 or higher, higher HEI scores were associated with SHR of 0.72 (95% CI, 0.57-0.93) per 1-SD increase and with SHR of 0.73 (95% CI, 0.57-0.94) for E-HEI scores.

  • Neither DII nor E-DII scores were significantly associated with the risk of reclassification. For grade reclassification to GG2 or greater, SHR was 1.08 (95% CI, 0.93-1.26) per 1-SD increase in DII and 1.02 (95% CI, 0.86-1.21) for E-DII.

In conclusion, adherence to American dietary guidelines as measured by the HEI was associated with a reduced risk of prostate cancer grade reclassification among men on active surveillance for GG1 prostate cancer. These findings support the idea that diet quality could be a modifiable risk factor in prostate cancer management, especially among men who are at risk for disease progression to more aggressive cancer requiring curative therapy.

Reference:

Su, Z. T., Mamawala, M., Landis, P. K., de la Calle, C. M., Shivappa, N., Wirth, M., Hébert, J. R., Pavlovich, C. P., & Trock, B. J. (2024). Diet quality, dietary inflammatory potential, and risk of prostate cancer grade reclassification. JAMA Oncology. https://doi.org/10.1001/jamaoncol.2024.4406

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Topical corticosteroids treatment under occlusion effective in pediatric patients with severe Alopecia Areata: Study

A new study published in the journal of Clinical and Experimental Dermatology showed that a strong topical corticosteroid (TCS) occlusion may be effective against severe alopecia areata (AA) in pediatric patients. One of the most prevalent dermatological conditions in children is alopecia areata (AA), which is caused by an autoimmune attack on the hair follicles that is mediated by T cells. Youngsters and their families undergo psychological suffering as a result of AA’s poor clinical course in youngsters. The treatment regimens for AA, especially for severe AA, such as alopecia totalis (AT) and alopecia universalis (AU), are not universally agreed upon. High-potency topical corticosteroids (TCSs) are the most often utilized therapy for childhood AA in clinical practice.

Strong TCSs under occlusion have been the subject of a few prior investigations in cases with severe AA, however, there is currently little information regarding their safety and effectiveness in children under the age of ten. Thus, Young Yoon Lee and colleagues undertook this retrospective investigation to see if TCS treatment under occlusion would be a viable and safe therapeutic alternative for children with severe AA.

This study looked into the medical records of 23 children with AT or AU who were treated with a strong TCS for 8 hours while being covered with a plastic sheet. The research assessed clinical improvement using the Severity of Alopecia Tool (SALT). A SALT score of less than 20 at six months was the main outcome. To determine the long-term safety of TCS treatment on the hypothalamus–pituitary–adrenal axis, the study examined the shift in cortisol levels.

At 6 months, 19 out of 23 patients (83%) achieved SALT ≤ 20. During the 6-month follow-up period, 6 patients experienced a recurrence. Adrenal insufficiency was suspected in 4 cases. However, following a month of reducing the strength of TCS or switching to nonsteroidal therapies, the patients’ cortisol levels returned to normal. Also, the limited sample size and retrospective design were among the limitations observed. Overall, with cortisol levels monitored during the therapy and follow-up periods, this study indicates that a strong TCS administered under occlusion may be safe and effective in treating severe forms of AA in pediatric patients.

Source:

Lee, Y. Y., Lim, H. H., Son, S., Jin, S., Shin, J.-M., Hong, D.-K., Jung, K. E., Seo, Y.-J., Lee, T. K., Kim, Y.-M., & Lee, Y. (2024). Efficacy and safety of topical corticosteroid treatment under occlusion for severe alopecia areata in children: a single-centre retrospective analysis. In Clinical and Experimental Dermatology (Vol. 49, Issue 10, pp. 1125–1130). Oxford University Press (OUP). https://doi.org/10.1093/ced/llae085

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Enzymatic cleaners fail to decontaminate and establish sterile surface in used healing abutments: Study

A study published in The International Journal of Oral & Maxillofacial Implants suggests that enzymatic cleaners fail to decontaminate and establish a sterile surface in used healing abutments.

A study was done to evaluate four decontamination strategies utilizing enzymatic agents available in most clinical settings to determine (1) the amount of biomaterial that can be removed in a group of previously used healing abutments (uHAs) and (2) the degree to which the decontaminated healing abutments are capable of inducing an inflammatory response in vitro compared to new healing abutments. In total, 50 healing abutments were collected following 2 to 4 weeks of intraoral use and distributed randomly into five test groups (groups A–E; n = 10 per group). Group A used enzymatic cleaner foam and an autoclave. Group B used an ultrasonic bath with enzymatic cleaner and an autoclave. Group C used a prophy jet, enzymatic cleaner foam, and an autoclave. Group D used a prophy jet, an ultrasonic bath with an enzymatic cleaner, and an autoclave. Lastly, group E used a prophy jet and an autoclave. The control group consisted of 10 new and sterile HAs. Residual protein concentration was determined by a Micro BCA protein assay (Thermo Fisher Scientific) while healing abutments from each group were stained with Phloxine B and macroscopically examined for the presence of debris. Human primary macrophages were exposed to healing abutments to examine the inflammatory potential, and supernatant levels of nine cytokine and chemokine profiles were analyzed using a multiplex bead assay. Results: All test groups showed differences in the degree of visual decontamination compared to controls. Groups D and E displayed the most effective surface debris removal and reduced protein concentration, while group A was the least effective. However, compared to controls, all test groups showed high levels of inflammatory cytokine secretion via multiplex assay for up to 5 days. The study found that decontaminating used healing abutments utilizing enzymatic cleaners failed to reestablish inert healing abutment surfaces and prevent an inflammatory immune response in vitro. Clinicians should not reuse healing abutments even after attempts to decontaminate and sterilize healing abutments surfaces.

Reference:

Abreu OJ, Estepa AV, Naqvi AR, Nares S, Narvekar A. Assessment of Detoxification Strategies for Used Dental Implant Healing Abutments: Macroscopic and Biologic Implications. Int J Oral Maxillofac Implants. 2024 Aug 29;39(4):516-525. doi: 10.11607/jomi.10651. PMID: 37910839.

Keywords:

Enzymatic, cleaners, fail, decontaminate, establish, sterile, surface, use, healing abutments, Study, Abreu OJ, Estepa AV, Naqvi AR, Nares S, Narvekar A


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Piroxicam and Paracetamol Ineffective in Preventing Renal Colic Recurrence: Study

A recent study published in the Academic Emergency Medicine revealed that common pain relievers, piroxicam and paracetamol, do not significantly reduce pain recurrence or prevent emergency department (ED) readmissions in patients treated for renal colic (RC). The study assessed the efficacy and safety of these medications in managing pain after patients were discharged from the ED.

This prospective, randomized, single-blind trial was conducted across four emergency departments. A total of 1,383 adults with RC were included in the study and were randomly assigned to receive either piroxicam, paracetamol, or a placebo for 5 days following their discharge from the ED. The primary focus was to determine if these medications could prevent pain recurrence and reduce the likelihood of patients returning to the ED within 7 days. Secondary outcomes included the time to pain recurrence and any side effects associated with the treatments.

The results indicated no significant differences in the efficacy of piroxicam or paracetamol when compared to the placebo in preventing pain recurrence. Pain recurrence within 7 days was observed in 29% of patients in the piroxicam group, 30.3% in the paracetamol group, and 30.8% in the placebo group. These figures suggest that the use of either piroxicam or paracetamol does not provide any substantial advantage in managing post-ED discharge pain for RC patients.

Further analysis showed that most patients who underwent pain recurrence did so within the first 2 days after discharge. Also, 86% of patients in both the piroxicam and placebo groups, and 84.1% in the paracetamol group, reported pain recurrence within this period. These findings highlight the early and acute nature of pain recurrence in RC patients, regardless of the treatment given. Emergency department readmission rates were similarly unaffected by the choice of medication. The study reported readmission rates of 20.8% for the piroxicam group, 23.8% for the paracetamol group, and 22.9% for the placebo group, with no statistically significant differences between the groups.

An important aspect of the study was the assessment of treatment-related side effects. The piroxicam group reported a significantly higher incidence of adverse effects when compared to the other groups. This finding raises concerns about the safety profile of piroxicam, especially given its lack of efficacy in preventing pain recurrence. Overall, the study suggests that neither piroxicam nor paracetamol is effective in preventing pain recurrence or reducing ED readmissions in RC patients. 

Source:

Jaballah, R., Toumia, M., Youssef, R., Ali, K. B. H., Bakir, A., Sassi, S., Yaakoubi, H., Kouraichi, C., Dhaoui, R., Sekma, A., Zorgati, A., Beltaief, K., Mezgar, Z., Khrouf, M., Bouida, W., Grissa, M. H., Saad, J., Boubaker, H., Boukef, R., … Nouira, S. (2024). Piroxicam and paracetamol in the prevention of early recurrent pain and emergency department readmission after renal colic: Randomized placebo‐controlled trial. In Academic Emergency Medicine. Wiley. https://doi.org/10.1111/acem.14996

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Males exhibit more morbidity after Cholecystectomy in Biliary Acute Pancreatitis, suggests study

A new study found that cholecystectomy is associated with an increased risk of morbidity in males but no difference in mortality between genders in those having Biliary acute pancreatitis (BAP). The study results were published in The American Journal of Surgery.

Acute pancreatitis (AP) is inflammation of the pancreas associated with increased morbidity and mortality. It shows severe symptoms ranging from systemic inflammatory response syndrome (SIRS) to organ failure. AP is triggered by various factors like biliary or gallstones or pancreatic issues. Biliary acute pancreatitis (BAP) is a milder variant with a self-limiting course of disease. However, severe forms can carry a substantial risk of morbidity and mortality.

Also Read: Application of 3D visualization technology facilitates repair of bile duct injury during laparoscopic cholecystectomy: Study

Cholecystectomy is the standard of care surgery for mild to moderate BAP. Research in the past has shown that gender plays a major role in the presentation of BAP as females develop gallstones at a younger age and males develop the same at a later age. The postoperative outcomes are ambiguous after cholecystectomy between the genders. Hence, researchers from the Department of Surgery, Western Michigan University Homer Stryker M.D. School of Medicine, USA conducted a study to evaluate whether gender is associated with worse 30-day postoperative outcomes following cholecystectomy for BAP.

A retrospective study was carried out by collecting data from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Individuals who are 18 years or older who underwent laparoscopic and open cholecystectomy with and without cholangiogram and/or common bile duct exploration were included. Gender stratification was done, 30-day postoperative outcomes were analyzed and both univariate and multivariable logistic regressions were performed.

Findings:

• About 4,158 (1556 male, 2602 female) patients were examined.

• A significantly higher rate of both serious and overall morbidity was seen in males than in females.

• The mean (SD) operative time was longer in the male group than in the female group.

• The length of stay in the hospital was more in males with males spending more than 7 days

• Multivariable analysis showed that male gender was an independent predictor of serious morbidity.

• No difference in mortality between the two groups was noted.

Also Read: Robotic cholecystectomy safe alternative to laparoscopic approach for gallbladder surgery: Study

Thus, the study concluded that the 30-day post-operative outcomes were significantly higher in males with higher serious and overall morbidity following cholecystectomy than in females. Males experience a more severe disease process than females even though the mortality rates are similar between both of them. This study throws light on the peri-and post-op management of male patients after cholecystectomy.

Further reading: Gender Variations in 30-day Outcomes Following Cholecystectomy in Patients with Biliary Acute Pancreatitis. Stevens Nicholas et al. The American Journal of Surgery. 0002-9610. Elsevier. Doi: 10.1016/j.amjsurg.2024.116034

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Study Finds Red and Green LED Light Therapies Effective in Boosting Hair Growth for Androgenetic Alopecia

Thailand: A recent comparative study has shed light on the effectiveness of red and green LED light therapies in managing androgenetic alopecia (AGA), a common form of hair loss affecting millions worldwide.

The research published in Photodermatology, Photoimmunology, and Photomedicine revealed that red and green LED therapies significantly promoted hair growth, enhancing density and thickness over six months. Notably, red LED therapy showed greater improvements in certain metrics. As a result, both therapies offer safe and effective alternatives for managing androgenetic alopecia, broadening the range of available treatment options.

Androgenetic alopecia, often referred to as male or female pattern baldness, is characterized by progressive hair thinning and loss due to genetic and hormonal factors. While existing treatments such as minoxidil and finasteride have limitations in efficacy and potential side effects, low-level light therapy (LLLT) utilizing red or near-infrared light has emerged as a promising alternative. Recent animal studies indicate possible advantages of green LED light, although data on its effects in humans remain limited.

To address this knowledge gap, Jitlada Meephansan, Samitivej Sukhumvit Hospital, Bangkok Dusit Medical Services PLC, Bangkok, Thailand, and colleagues evaluated the impact of both light therapies on hair growth, density, and thickness in individuals experiencing this condition.

For this purpose, the researchers designed an innovative LED helmet that emitted red and green light on opposite halves of the frontal scalp, delivering an energy density of 40 J/cm² over a 20-minute session. The study employed clinical photography, physician evaluations on a 7-point scale, patient satisfaction surveys, and measurements of hair density and diameter. Data analysis utilized linear mixed-effects models, with significance determined.

The following were the key findings of the study:

  • Seventeen participants were involved in the study (47.1% male, 52.9% female), with an average age of 46.47 years.
  • After 6 months of treatment, participants showed significant improvements in various metrics.
  • Both red and green LED therapies notably increased:
    • Hair diameter
    • Non-vellus hair density
    • Patient satisfaction scores
  • Red LED therapy resulted in:
    • A statistically significant decrease in vellus hair density.
    • A greater increase in hair diameter compared to green LED therapy.
  • Minimal adverse effects were reported, primarily consisting of:
    • Tolerable scalp heat
    • Mild redness of the scalp.

The findings showed that red and green LED light therapies deliver promising results for patients with androgenetic alopecia, with red LED therapy typically yielding more sustained positive effects.

“Incorporating red LED therapy into a comprehensive treatment plan is advisable for patients who can invest in it,” the researchers concluded.

Reference:

Tantiyavarong, J., Charoensuksira, S., Meephansan, J., Hanvivattanakul, S., Rayanasukha, Y., Boonkoom, T., & Tantisantisom, K. (2024). Red and Green LED Light Therapy: A Comparative Study in Androgenetic Alopecia. Photodermatology, Photoimmunology & Photomedicine, 40(6), e13004. https://doi.org/10.1111/phpp.13004

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FDA approves new dose of immediate release abuse-deterrent oxycodone

The US Food and Drug Administration has approved RoxyBond 10 mg immediate-release tablet for managing pain requiring an opioid analgesic for which there are no adequate alternative treatments.

ROXYBOND is the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes.

ROXYBOND is formulated with SentryBond™ abuse-deterrent technology. This patented technology combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse, even if it is subjected to physical manipulation and/or chemical extraction. SentryBond is designed to maintain the intended release profile of extended-release (ER) products and delay the release of IR products.

“The FDA approval of ROXYBOND 10 mg with SentryBond is a significant milestone for Protega and fulfills an unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated,” said Paul Howe, Chief Commercial Officer of Protega. “When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject.”

Protega’s innovative SentryBond technology is a first-of-its-kind abuse-deterrent patented technology. It is designed to provide multiple levels of protection that resist physical manipulation, chemical extraction, and manipulation or transformation for injection. Protega’s proprietary SentryBond technology platform could potentially be utilized in other medications to help deter misuse and abuse, e.g., hydromorphone, hydrocodone, and attention deficit hyperactivity disorder (ADHD) medications. While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.

“The development of ROXYBOND with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, Ph.D., VP Medical and Regulatory Affairs for Protega. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse. We look forward to responsibly launching ROXYBOND 10 mg and advancing our innovative technology platform for potential application in other commonly abused prescription medications.”

More than 2000 in vitro tests were conducted to demonstrate ROXYBOND tablets were difficult to manipulate vs oxycodone IR1,2, this data, along with the results of the human abuse potential study, suggest that the physicochemical properties of ROXYBOND are expected to reduce abuse via the intranasal and intravenous routes of administration. However, abuse is still possible by intranasal, intravenous, and oral routes.2

In addition to the FDA approval for the 10 mg tablet, ROXYBOND was previously approved and is already available in 5 mg, 15 mg, and 30 mg tablets. Protega plans to launch ROXYBOND 10 mg before the end of the year, providing clinicians with another risk mitigation tool they can use when treating patients with severe pain.

The addition of ROXYBOND 10 mg can enhance flexibility and precision in opioid therapy, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions. For physicians, it can allow for more flexible dosing for pain levels, better titration, and help optimize risk management across diverse patient populations.

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IQVIA Gets CDSCO Panel Nod to Study KarXT in Schizophrenia

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to IQVIA RDS (India) for conducting the trial of KarXT, a combination of Xanomeline Tartrate and Trospium Chloride.

This came after the firm presented phase III clinical study protocol no. KAR-013 version 5.0 dated 02 Nov 2023. This is an open-label extension study to assess the long-term safety and tolerability of adjunctive KarXT in subjects with inadequately controlled symptoms of schizophrenia.

Xanomeline is a dual M1 and M4-preferring muscarinic receptor agonist that does not block D2 dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors.

At the recent SEC meeting for Neurology and Psychiatry held on 16th October 2024, the expert panel reviewed the phase III clinical study protocol no. KAR-013 version 5.0 dated 02 Nov 2023.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the condition that protocol no. KAR-012 shall be approved by CDSCO.

Also Read: CDSCO Panel Approves Novartis Protocol Amendment Proposal to study Ribociclib

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Sanofi gets CDSCO Panel nod to study Amlitelimab

New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical study of Amlitelimab.

However, this approval is subject to the requirement that the firm submit a separate detailed protocol and procedure to ensure standardized monitoring across all the study sites, specifically a detailed document informing investigators about screening for cutaneous/extracutaneous lymphoma steps of diagnosis and reporting to CDSCO.

This came after Sanofi presented Phase III clinical study protocol No. EFC17600 version no. 1 dated 01.02.24.

Amlitelimab is a fully human, non-depleting, anti-OX40L monoclonal antibody that binds to OX40L on APCs, preventing interaction with OX40 on activated T cells.

The mechanism of action for Amlitelimab is centered around its ability to inhibit the interaction between the OX40 receptor and its ligand, OX40L. The OX40 receptor is expressed on the surface of activated T cells, a type of immune cell that plays a crucial role in the body’s immune response. Amlitelimab inhibits OX40-OX40L interaction and can be used in the research of atopic dermatitis.

At the recent SEC meeting for dermatology and allergy held on 8th October 2024, the expert panel reviewed the Phase III clinical study protocol No. EFC17600 version no. 1 dated 01.02.24.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial with the condition that the firm should submit to CDSCO a separate detailed protocol and procedure to ensure standardized monitoring across all the study sites, specifically a detailed document informing investigators about screening for cutaneous/extracutaneous lymphoma steps of diagnosis and reporting.

Also Read: Received CDSCO nod for Nafithromycin Antibiotic for CABP, says Wockhardt

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