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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-13T18:00:01+05:30 | Updated On 13 May 2024 6:00 PM IST

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.

Also Read: Submit Data on Paracetamol-Tapentadol Combination: CDSCO Panel tells MSN Laboratories

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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-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