Zydus Gets CDSCO panel Nod for BE Study Of Antineoplastic Drug Relugolix
New Delhi: In response to the drug major Zydus proposal for manufacture and market of anticancer drug Relugolix Tablets 120mg along with bioequivalence study protocol, the Subject Expert Committee (SEC) functional under the Central Standard Drug Control Organization (CDSCO) has granted permission to conduct bioequivalence study as per the protocol.
However, the approval is subject to the condition the firm should revise the protocol with respect to inclusion criteria to enroll the subjects with higher age groups between the ages of 35-45 years who have completed the family planning.
This came after the firm presented its proposal for the manufacture and market of the drug Relugolix Tablets 120mg along with bioequivalence study protocol and justification for waiver of Phase III clinical trial before the committee.
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and pharmacokinetic/pharmacodynamic (PK/PD) parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
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.
After detailed deliberation, the committee recommended the grant of permission to conduct BE study as per the protocol presented subject to the condition that the firm should revise the protocol with respect to inclusion criteria to enroll the subjects with higher age group between the ages 35-45 years who have completed the family planning.
