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  • Insufficient CT data...

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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-31T18:00:11+05:30  |  Updated On 31 July 2024 6:00 PM IST
Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets
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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.

Also Read: CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal to Study anti-cancer Drug Capivasertib

Alkem Laboratoriescdscorelugolix tabletbioequivalence studyphase 3 trial
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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