The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the humanized monoclonal antibody galcanezumab (Emgality, Eli Lilly) for migraine prevention in adults.
The indication for the drug is as treatment only for patients who have at least 4 monthly migraine days (MMDs).
The once-monthly, self-injectable drug is the second calcitonin gene-related peptide (CGRP) antagonist to receive the committee's recommendation for migraine prevention. As reported by Medscape Medical News, the EU panel endorsed erenumab (Aimovig, Amgen/Novartis) in May 2018.
The US Food and Drug Administration is expected to give an answer on galcanezumab by the end of this month, following its approval earlier this year of erenumab and another anti-CGRP agent, fremanezumab-vfrm (Ajovy, Teva), for prevention of migraine.
The CHMP's recommendation today is based on three phase 3 trials: EVOLVE-1, EVOLVE-2, and REGAIN, with total participants including 1117 patients with chronic migraine and 1780 patients with episodic migraine.
Among those treated with the active drug, patients with chronic migraine had an average reduction of 2 MMDs compared with placebo, while those with episodic migraine had an average reduction of 1.9 MMDs.
The most commonly reported adverse events were injection site pain and reactions, vertigo, and constipation.
"It is estimated that approximately 15% of the population of the European Union suffers from migraine," the CHMP reports in a statement.
"There is no cure for migraine and these two medicines [galcanezumab and erenumab] widen the therapeutic options for this disease," they add. "There are other available treatments to tackle the symptoms and reduce the frequency of migraine days. However, existing preventative treatments do not always work well and may have unpleasant side effects."
"If approved, we're very excited about the potential to offer Emgality as a new option for migraine prevention that could provide more migraine-free days to people living with this debilitating disease," Gudarz Davar, MD, vice president, Neurology Department at Lilly Bio-Medicines, said in a press release.
The opinion from the CHMP will now be sent to the European Commission for a decision on EU-wide marketing authorization.
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Cite this: CHMP Backs Galcanezumab for Migraine Prevention - Medscape - Sep 21, 2018.