Conduct bioequivalence Study of Elagolix tablets: CDSCO panel tells Hetero Labs
New Delhi: In response to the proposal presented by the drug major Hetero Labs to manufacture and market Elagolix tablet 150mg and 200mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended conducting the bioequivalence (BE) study.
This came after Hetero Labs presented the proposal for a grant of permission to manufacture and market the drug Elagolix tablets 150mg and 200mg along with a bioequivalence study waiver and Phase III clinical trial protocol before the committee.
Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. 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).
Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder. The growth of these lesions is dependent upon the estrogen hormone
At the recent SEC meeting for Reproductive and Urology held on 21st June 2023, the expert panel reviewed the proposal presented by Hetero Labs for a grant of permission to manufacture and market the drug Elagolix tablets 150mg and 200mg along with bioequivalence study waiver and Phase III clinical trial protocol.
After detailed deliberation, the committee opined that the firm should conduct BE study. Accordingly, the expert panel suggested that the firm should submit BE study protocol for review by the SEC.
