Shots:

• The NDA submission is based on the P-III ADVANCE study- pivotal P-IIb/III study- and the P-III LTS study for Atogepant in 2-500+ patients. The P-III ADVANCE study involves assessing Atogepant (PO- 10/30/60mg) vs PBO in 910 patients who experienced 4-14 migraine days/mos.
• The P-III ADVANCE and P-IIb/III study met its 1EPs showed a reduction in mean monthly migraine days over a 12wks. treatment period. Additionally- 30 and 60 mg doses met all six 2EPs in the P-III study
• The P- III LTS study evaluating Atogepant (PO- 60mg- qd) for 52wks.- findings will be presented at the AAN 2021. The company is anticipating a regulatory decision in late Q3’21

  Ref: PRNewswire | Image: abbvie