BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension

New Delhi: In a significant development, BDR Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anticancer drug Abiraterone Acetate Oral Suspension 1000 mg/5 ml.

The nod came along with a phase III clinical trial waiver with the condition to conduct a phase IV clinical trial in 400–500 subjects.

This took place after BDR Pharmaceuticals presented its justification for the waiver of the Phase III clinical trial before the committee.

The firm has informed that the proposed drug formulation, Abiraterone Acetate Oral Suspension 1000 mg/5ml, has no change in route of administration and no change in dosing regimen.
“Abiraterone Acetate 1000 mg tablets approved in the EU by 2021,”  the firm added.

Abiraterone is an antiandrogen used in the treatment of metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis.

At the recent SEC meeting for oncology held on May 15, 2024, the expert panel reviewed the justification for waiver of the Phase III clinical trial of the anticancer drug Abiraterone Acetate.
After detailed deliberation, the committee has opined for the grant of manufacturing and marketing of Abiraterone Acetate Oral Suspension 1000 mg/5 ml along with a Phase III clinical trial waiver with the condition of conducting a Phase IV clinical trial in 400–500 subjects.
Accordingly, the expert panel suggested that the firm submit the Phase IV Clinical Trial protocol within 3 months from the date of approval of the product to CDSCO for further review by the committee.

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