Skip to main content

Market Overview

FDA Accepts AbbVie's Atogepant US Review Application For Migraine

Share:
  • The FDA has accepted for review AbbVie Inc's (NYSE: ABBV) marketing application seeking approval for Atogepant for the preventive treatment of migraine in adults who meet the criteria for episodic migraine.
  • The regulatory decision is expected in late Q3 2021.
  • Atogepant is an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist.
  • The NDA is supported by data from a clinical program evaluating the efficacy, safety, and tolerability of orally administered Atogepant in nearly 2,500 patients who experience 4-14 migraine days per month, including Phase 3 ADVANCE study, Phase 2b/3 study, and the Phase 3 long-term safety study.
  • Price Action: ABBV shares are up 0.16% at $106.9 in premarket trading on the last check Tuesday.
 

Related Articles (ABBV)

View Comments and Join the Discussion!

Posted-In: MigrainesBiotech News Health Care FDA General

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com