Pfizer Gets CDSCO Panel Nod To Conduct Phase III CT of Rimegepant
New Delhi: Pharmaceutical major Pfizer has received the go-ahead from the Subject Expert Committee (SEC), which is functional under the Central Drug Standard Control Organisation (CDSCO), to conduct the Phase III clinical study of the calcitonin gene-related peptide receptor antagonist Rimegepant.
This came after the firm presented Phase III clinical study protocol no. C4951013 amendment 1 dated 19.03.2024.
However, this approval is subjected to a condition that the firm should enrol the paediatric subjects of at least 40kg weight.
Rimegepant is a small molecule inhibitor of the calcitonin gene-related peptide (CGRP) receptor that blocks the action of CGRP, a potent vasodilator believed to play a role in migraine headaches.
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults.
Rimegepant is an antagonist of the calcitonin gene-related peptide receptor 1 - it competes with CGRP for occupancy at these receptors, preventing the actions of CGRP and its ability to amplify and perpetuate migraine headache pain, ultimately terminating the headache.
Rimegepant belongs to a new generation of treatments for acute migraine headaches. The drug is awaiting approval from the U.S. Food and Drug Administration and give benefits over migraine medicines presently available.
Earlier, the Medical Dialogues Team had reported that the expert panel rejected the firm's proposal for a local Phase III clinical trial waiver and recommended conducting the randomized controlled Phase III clinical trials of Rimegepant orally disintegrating tablet (ODT) 75 mg in Indian population.
At the recent SEC meeting for Neurology and Psychiatry, held on 29 October 2024, the expert panel reviewed the Phase III clinical study protocol no. C4951013 amendment 1, dated 19.03.2024.
After detailed deliberation, the committee recommended that permission to conduct the trial as presented by the firm be granted, with the condition that pediatric subjects of at least 40kg weight be enrolled.
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