AbbVie Reports the US FDA's Acceptance of NDA for Atogepant as a Preventive Treatment for Migraine
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
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com