Intas Pharmaceuticals Gets CDSCO Panel Nod to Study R-hFSH Solution for Injection
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical trial of R-hFSH (Follitropin alfa) Solution for Injection 900 IU/ 1.44 mL.
This came after the firm presented the clinical study protocol to conduct Phase III clinical trial titled “A Randomized, Assessor-Blind, Active-Controlled, Parallel Group, Two-Arm, Phase-3 Study To Compare Safety, Efficacy and Immunogenicity of R-hFSH (Recombinant Human Follicle Stimulating Hormone (Follitropin Alfa) Injection of Intas Pharmaceuticals Ltd., With Recombinant Human Follicle Stimulating Hormone (r-hFSH) Follitropin Alfa (Gonal-F) of Merk Serono Ltd. in Adult Females undergoing Assisted Reproductive Technology” vide Protocol no. 0232-4 Version 1.0 dated 17.07.2024.
Follitropin alfa is a human FSH preparation of recombinant DNA origin. Follitropins stimulate ovarian follicular growth in women who do not have primary ovarian failure, and stimulate spermatogenesis in men with hypogonadotrophic hypogonadism. FSH is required for normal follicular growth, maturation, gonadal steroid production, and spermatogenesis.
At the recent SEC meeting for Reproductive held on October 23, 2024, the expert panel reviewed the proposal presented by Intas Pharmaceuticals to conduct the Phase III clinical trial of R-hFSH (Follitropin alfa).
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial as per the protocol presented by the firm, with the condition that more tertiary care centers and government sites be included in the study.
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