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.

  | Ref: PR Newswire | Image: abbvie