Alkem Laboratories Gets CDSCO Panel Nod To Manufacture Market Relugolix Tablets 120mg

New Delhi: Alekm Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Relugolix Tablets 120 mg.

However, this approval is subject to a condition that the firm conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.

This came after Alekm Laboratories presented the bioequivalence (BE) study report along with other documents:

1. Justification/clarification regarding significant inter-subject variability in presented BE study data.
2. Published Pharmacokinetic-Pharmacodynamic (PK/PD) data
3. Data on the ratio of serum to CSF concentration
4. Minimum effective concentration in CSF required for pharmacological action of the proposed drug.

Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions. It was first approved in Japan in 2019, under the brand name Relumina, for the symptomatic treatment of uterine fibroids, and more recently by the United States’ FDA in 2020, under the brand name Orgovyx, for the treatment of advanced prostate cancer. This branded product was later approved by the European Commission on April 29, 2022. Relugolix has also been studied in the symptomatic treatment of endometriosis.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer. Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. In a combination product with estradiol and norethindrone, relugolix is indicated for the once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Relugolix works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

At the recent SEC meeting for Oncology held on 7th May 2024, the expert panel reviewed the BE study report along with other documents presented by the drug major Alkem Laboratories.

The committee noted that the drug was already approved in the country on 16.10.2023.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Relugolix tablets 120mg with the condition that the firm should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.

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