Eli Lilly gets CDCSO panel nod to import, market Galcanezumab

This came after the drug major Eli Lilly presented the Phase III global clinical trial results in which India was one of the participating countries for import and market of Galcanezumab 120mg/ml injection (single dose prefilled pen and prefilled syringe).

Galcanezumab is a humanized monoclonal antibody developed by Eli Lilly and Company against human calcitonin gene-related peptide (CGRP). Galcanezumab was approved by the FDA in September 2018, and is indicated for the preventive treatment of migraine and the treatment of episodic cluster headache.

Galcanezumab is a calcitonin-gene-related peptide antagonist that targets and binds calcitonin gene-related peptide (CGRP). Research has demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy. Also, it has been shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.

Therefore, binding to CGRP to interfere with its activity was specifically designed as the mechanism of action for galcanezumab. This was 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. Moreover, studies have shown that humanized monoclonal antibodies against CGRP have successfully decreased the frequency of migraine headaches in early clinical trials as a preventative therapeutic.

At the recent SEC meeting for Neurology and Psychiatry held on 17th January 2023, the expert panel reviewed the Phase III global clinical trial results in which India was one of the participating countries for import and market of Galacanezumab 120mg/ml injection (single dose prefilled pen and prefilled syringe) which was presented by the drug maker Eli Lilly.

The expert panel noted that the drug is approved in 48 countries globally including USA, EU, Japan, Switzerland, UK, Canada, Brazil, Australia.

After detailed deliberation, the committee noted the results of the study and recommended for grant of permission to import and market the drug with the condition that the firm should conduct Phase IV clinical trial including evaluation with respect to neutralizing antibody as an endpoint.

In accordance with the above, the expert panel directed that the firm should submit the Phase IV clinical trial protocol to CDSCO within three months of import and marketing approval.