AbbVie’s Qulipta (atogepant) Receives the US FDA’s Approval for the Treatment of Migraine

Shots:

• The approval was based on a clinical program including P-III ADVANCE study, P-IIb/III study & P-III LTS study evaluated the safety, efficacy & tolerability of Qulipta (PO, 10/30/60mg) vs PBO in 2000 patients with EM who experienced 4-14 migraine days/mos.
• The P-III ADVANCE & P-IIb/III study met its 1EPs i.e., reduction in mean monthly migraine days @12wks. for all 3 doses. The 2EPs of the P-III trial showed that the proportion of patients achieved a 50-100% reduction in monthly migraine days (56%/59%/61% vs 29.0%) @12wks. & all doses were well tolerated in both studies
• In the P-III study, patients treated with 60mg dose experienced a 4.2-day reduction from a baseline of 7.8 @12wks.

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