- 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
Click here to read full press release/ article | Ref: PRNewswire | Image: The Wall Street Journal