Conduct Randomized Control Phase III CT in Indian Population: CDSCO Panel Tells Pfizer on Rimegepant
Pfizer
New Delhi: Rejecting the proposal for local Phase III clinical trial waivers, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Pfizer to conduct the randomized controlled Phase III clinical trials of Rimegepant orally disintegrating tablet (ODT) 75 mg in Indian population.
This came after the drug maker Pfizer presented its proposal for a grant of permission to import and market Rimegepant ODT 75 mg, with a request for a local Phase III clinical trial waiver and Clinical Trial reports of other countries for the Rimegepant ODT 75mg.
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 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 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.
At the recent SEC meeting for Neurology and Psychiatry held on15th February 2024, the expert panel reviewed the proposal presented by the drug major Pfizer for a grant of permission to import and market Rimegepant ODT 75 mg, with a request for a local Phase III clinical trial waiver and Clinical Trial reports of other countries for the Rimegepant ODT 75mg.
After detailed deliberation, the committee did not approve the firm’s request for a Clinical Trial waiver in India.
In addition, the expert panel recommended that the firm should conduct the randomized controlled Phase III Clinical Trials in the Indian population.
Accordingly, the expert panel suggested that the Phase III clinical trial protocol should be submitted to CDSCO for review by the SEC committee.
