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Eli Lilly presented a post hoc analysis of its monthly migraine therapy galcanezumab, one of a new class of targeted preventive drugs, as it looks to show the drug's effectiveness after the failure of other treatments.
Currently under review at the FDA, galcanezumab may enter a potentially crowded field of monoclonal antibody (mAb) treatments designed to stop the calcitonin gene-related peptide (CGRP) believed to play a major role in migraines and cluster headaches.
Drugs with similar mechanisms of action have already been submitted to the agency, including Amgen and Novartis’ erenumab (Aimovig, with PDUFA on May 17) and Teva’s fremanezumab (PDUFA in June, although manufacturing issues may delay any launch until next year), while smaller biotech Alder expects to file an application for its eptinezumab infusion later in the year. Lilly, meanwhile, expects the FDA’s decision on galcanezumab in the third quarter.
Last May, Teva said the phase 3 Halo study of fremanezumab hit its endpoints. During the 12-week period after first dose, patients treated with the med saw statistically significant reduction in monthly moderate-or-above headache...