Zydus Lifesciences gets CDSCO panel nod to manufacture, market Relugolix Tablets
New Delhi: Noting an unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Zydus Lifescience to manufacture and market Relugolix Tablets 120mg indicated for the treatment of adult patients with advanced prostate cancer, with local Phase III clinical trial waiver subject to the condition that firm should conduct Phase IV clinical trial within 3 months of approval.
This came after Zydus Lifescience presented the innovator’s safety and efficacy data available in the public domain for the grant of permission to manufacture and market the drug Relugolix Tablets 120mg with a local Phase III clinical trial waiver.
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.
The mechanism of action of relugolix is as a Gonadotropin-Releasing Hormone Receptor Antagonist, Cytochrome P450 3A Inducer, Cytochrome P450 2B6 Inducer, and Breast Cancer Resistance Protein Inhibitor, P-Glycoprotein Inhibitor. The physiologic effect of relugolix is by means of Decreased GnRH Secretion.
Earlier, the Medical Dialogues Team had reported that in response to Zydus's proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets, the CDSCO panel had opined the firm to present the safety and efficacy data of the anticancer drug Relugolix (innovator).
In continuation to the above, at the recent SEC meeting for Oncology and Hematology held on 25th July 2023, Zydus Lifescience presented the innovator’s safety and efficacy data available in the public domain for the grant of permission to manufacture and market the drug Relugolix Tablets 120mg.
After detailed deliberation, the committee noted that Relugolix Tablets 120mg is approved in US and EU.
Furthermore, the committee noted that, at its meeting on March 28, 2023, it had already recommended that other firms be given permission to manufacture and sell Relugolix Tablets 120mg.
The committee also opined that there is an unmet medical need in the country.
In accordance with the above, the committee recommended the grant of permission to manufacture and market the drug Relugolix Tablets 120mg with a local Phase III clinical trial waiver subject to the condition that the firm should conduct a Phase IV clinical trial within 3 months of approval and accordingly Phase IV clinical trial protocol should be submitted to CDSCO.
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