Batch of EMA/CHMP recommendations from June 2023 meeting
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its June 2023 meeting.
The committee recommended granting a marketing authorization for AbbVie’s (NYSE: ABBV) Aquipta (atogepant monohydrate), intended for the prophylaxis of migraine in adults who have at least four migraine days per month. It is estimated that approximately 15% of the EU population suffers from migraine, a type of headache characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head.
If approved, atogepant would be the first daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the prophylaxis treatment of migraine in Europe, according to AbbVie’s statement on the CHMP opinion.
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