Sun Pharma Industries Gets CDSCO Panel Nod To Manufacture Market Elagolix Tablets 150 mg,200 mg

New Delhi: With the condition to be sold by retail under the prescription of a Gynaecologist only, pharmaceutical major Sun Pharma Industries has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSCO to manufacture and market Elagolix tablets 150mg and 200mg.

However, this nod is subjected to a condition that the firm should conduct the Phase IV clinical trial (CT) on Elagolix 200 mg tablet for which Phase IV clinical trial protocol is required to be submitted to CDSCO within 3 months.

In addition to the above, the expert panel mentioned that the said drug should be sold by retail under the prescription of a Gynaecologist only.

This came after Sun Pharma Industries presented the Phase III CT report of Elagolix 150mg tablet and therapeutic justification and rationale for Elagolix 200 mg tablets.

Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body. Elagolix works by decreasing the body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding).

At the recent SEC meeting for Reproductive held on 20th March 2024, the expert panel reviewed the Phase III CT report of Elagolix 150mg tablet and the therapeutic justification and rationale for Elagolix 200 mg tablets.

After detailed deliberation, the committee recommended the grant of manufacturing and marketing of Elagolix 150mg and 200mg for the proposed indication subject to the condition that

(a) The firm should conduct Phase IV CT on Elagolix 200 mg tablet for which Phase IV CT protocol is to be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

(b) To be sold by retail under the prescription of a Gynaecologist only.

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