Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets
New Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Alkem Laboratories to conduct a bioequivalence study of Relugolix Tablets 40 mg as per the protocol presented by the firm.
Furthermore, the expert panel opined that the firm should 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.
This came after Alkem Laboratories presented the proposal for the grant of permission to manufacture and market Relugolix 40 mg tablets (Additional Strength) along with the Bioequivalence (BE) study protocol and justification for the waiver of the Phase III clinical trial before the committee.
The firm mentioned that Relugolix 40 mg tablets were approved in Japan in 2019, and the FDC of Relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg was approved in the USA in 2022.
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.
