- The FDA has approved AbbVie Inc's (NYSE: ABBV) Humira (adalimumab) to treat moderately to severely active ulcerative colitis in pediatric patients five years and older.
- Approved dosing for HUMIRA will be determined based on the child's weight.
- The approval was based on results from Phase 3 ENVISION I study, which showed that the higher dosage of Humira induced clinical remission in 60% of patients at Week 8 and 45% of patients, who responded at Week 8, were in remission at Week 52.
- Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence, weight loss, and fatigue.
- Price Action: ABBV closed 2.3% higher at $108.69 on Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
