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Local CT waiver will be considered after submission of BE study result: CDSCO panel tells Synokem on Relugolix

By - Dr. Divya Colin
Published On 2023-05-02 12:30 GMT   |   Update On 2023-05-02 12:30 GMT
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New Delhi: Granting approval to conduct the bioequivalence study of Relugolix, an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested that local clinical trial waiver will be considered after submission of the results of the Bioequivalence study.

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This came after the drug major Synokem Pharmaceuticals presented the proposal for the manufacture and marketing of the drug Relugolix film-coated tablet 40mg along with the Bioequivalence study protocol and justification for waiver of Phase III of the clinical trial before the committee.

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.

Also Read:Pfizer, Myovant Sciences get USFDA nod for MYFEMBREE

In May 2021, the FDA approved the combination product made up of relugolix, estradiol, and norethindrone under the market name Myfembree for the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

At the recent SEC meeting for Reproductive and Urology held on 23rd March 2023, the expert panel reviewed the proposal for the manufacture and marketing of the drug Relugolix film-coated tablet 40mg along with the Bioequivalence study protocol and justification for waiver of Phase III of the clinical trial.
After detailed deliberation, the committee recommended the grant of permission to conduct the bioequivalence study as per the protocol presented.
In addition to the above, the committee also opined that local clinical trial waiver will be considered after the submission of the results of the Bioequivalence study.
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Dr. Divya Colin

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.

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