Lilly Research Laboratories's galcanezumab moved into the lead in the treatment of cluster headaches with a calcitonin gene-related peptide (CGRP) inhibitor via Phase III data reported May 15, but analysts wonder how much of an impact this will have in the ultra-competitive CGRP space.
The Indianapolis pharma said that galcanezumab hit the primary endpoint in a 106-patient, Phase III study in episodic cluster headaches, but it failed to show statistical significance in a larger Phase III in chronic cluster headache. Galcanezumab is under review at the US FDA for migraine prevention with an Oct. 11 PDUFA date, but Amgen Inc. and Novartis AG are expected to have the first anti-CGRP drug approved for migraine prophylaxis with a May 17 action date for their Aimovig (erenumab)
