Conduct BE and Phase III CT: CDSCO Panel Tells Alkem On Elagolix Tablets
New Delhi: In response to the drug major Alkem Laboratories' proposal to manufacture and market the GnRH receptor antagonist Elagolix, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct the bioequivalence (BE) study and Phase-III clinical trial.
This recommendation is subject to the condition that the clinical trial sites should be equally distributed amongst government and private institutions and clinical trial sites should be geographically distributed in the country.
This came after the drug major Alkem Laboratories presented the proposal for a grant of permission for manufacturing and marketing of the drug Elagolix Tablets 150mg and 200mg along with a protocol for BE study and protocol for Phase-III the clinical trial before the committee.
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 your 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 and Urology held on the 26th of April 2023, the expert panel reviewed the proposal to manufacture and market the drug Elagolix Tablets
After detailed deliberation, the committee recommended conducting the BE study and Phase-III clinical trial subject to the following conditions:
I. The clinical trial sites should be equally distributed amongst government and private institutions.
II. The clinical trial sites should be geographically distributed in the country.
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