AbbVie Receive EMA’s CHMP Positive Opinion Recommending Approval of Atogepant for the Preventive Treatment of Adults with Migraine
Shots:
- The EMA’s CHMP has adopted the positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have 4 or more migraine days per month
- The opinion was based on the P-III studies (PROGRESS) in 778 patients and (ADVANCE) in 910 patients evaluating atogepant vs PBO in chronic and episodic migraine. Both trials met their 1EPs & showed a reduction in mean monthly migraine days (MMDs) across the 12wk. treatment period, improvements in all 2EPs were seen & was well tolerated
- If atogepant is approved by EC, it will be the first oral calcitonin gene-related peptide (CGRP) receptor antagonist in the EU for the prophylaxis of migraine in adults
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie Presents P-III Study (ELEVATE) Results of Qulipta (atogepant) for the Preventive Treatment of Episodic Migraine at AAN 2023
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