AbbVie Reports the US FDA’s Acceptance of NDA for Atogepant as a Preventive Treatment for Migraine

 AbbVie Reports the US FDA’s Acceptance of NDA for Atogepant as a Preventive Treatment for Migraine

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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