AbbVie’s Qulipta (atogepant) Receives the US FDA's Approval for Expanded Indication in Adults with Chronic Migraine
- The approval was based on the P-III trial (PROGRESS) evaluating Qulipta (60mg, qd) vs PBO in adult patients
- The trial met its 1EPs i.e., a reduction from baseline in mean monthly migraine days across 12wk. treatment period & improvement in all six 2EPs incl. 50% reduction in mean MMDs @12wk. along with improvements in function & reduction in activity impairment due to migraine. The efficacy results were consistent with (ADVANCE) episodic migraine trial & overall safety profile was consistent with the EM patient population
- Qulipta, an oral CGRP receptor antagonist was available in the US for migraine in adults. The product is available in 10/30/60mg strengths for EM while a 60mg dose is indicated for chronic migraine patients
Ref: PRnewswire | Image: AbbVie
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