Submit scientific justification for increasing patients number in study: CDSCO Tells Eli Lilly on Galcanezumab

This came after the firm presented a protocol amendment in Protocol No.15Q-MC-CGAT(f) dated 22.04.2023 to increase in the number of Patients in India from 40 to 55, before the committee.

Galcanezumab is a humanized monoclonal antibody specifically developed for migraine prophylaxis. It acts by blocking the CGRP pathway by targeting the ligand itself.

Galcanezumab medication is used to help prevent migraine. It is also used to treat a certain type of headache (episodic cluster headache). Galcanezumab belongs to a class of drugs known as monoclonal antibodies.

Galcanezumab is a humanized monoclonal antibody that targets and binds calcitonin gene-related peptide (CGRP). Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.

Further, research has shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients. For these reasons, binding to CGRP to interfere with its activity was specifically designed as the mechanism of action for galcanezumab, in order to reverse the migraine-inducing activity of natural CGRP. By binding to natural endogenous CGRP, galcanezumab interferes with its activities by making it unable to bind to CGRP receptors.

At the recent SEC meeting for Neurology and Psychiatry held on 17 August 2023, the expert panel reviewed the proposal presented by the drug major Eli Lilly for the protocol amendment in Protocol No.15Q-MC-CGAT(f) dated 22.04.2023 to increase in number of Patients in India from 40 to 55.

After detailed deliberation, the committee recommended that the firm submit scientific justification for the request for an increase in the number of patients which is country-specific India.

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