AbbVie Reports Submission of MAA to EMA for Atogepant to Treat Migraine
Shots:
- The application was based on the P-III (ADVANCE) & (PROGRESS) studies evaluating atogepant (10/30/60mg) vs PBO in adult patients with EM & chronic migraine who have 4 migraine days/mos.
- Both the studies met their 1EPs & 2EPs i.e., 50% reduction in mean monthly migraine days for all doses @12wk., was well tolerated, and the overall safety profiles were consistent with safety findings observed in prior studies for the prophylaxis of EM & chronic migraine
- In (ADVANCE) trial, 55.6%/58.7%/60.8% of patients in the 10/30/60mg dose achieved 50% vs 29.0% reduction & meet ICHD criteria for migraine with/out aura. The MAA will be valid for all member states of the EU, Iceland, Lichtenstein, Northern Ireland & Norway
Ref: AbbVie | Image: AbbVie
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