Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets

However, the expert panel noted that the firm did not present sufficient clinical trial data in the female population for an applied indication.

Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It 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.

Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. In combination with estradiol and norethindrone, relugolix is indicated for the once-daily treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market Relugolix 40 mg tablets (Additional Strength) along with the BE study protocol and justification for the waiver of the Phase III clinical trial before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct a Bioequivalence study as per the protocol presented by the firm.

In addition, the expert panel stated to submit a bioequivalence study report along with clinical trial data on Indian patients or a Phase III clinical trial protocol to CDSCO for further consideration by the committee.

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