ENTX - AbbVie Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU | Benzinga
AbbVie (NYSE: ABBV) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of Skyrizi (risankizumab) in the EU to treat adults with moderately to severely active ulcerative colitis (UC).
The eligible patient population includes UC patients who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The recommended treatment regime with AbbVie's Skyrizi involves an intravenous induction dose of 1200 mg, followed by a subcutaneous maintenance dose of 180 mg or 360 mg, based on individual patient requirements.
Although not legally binding, the EMA will consider the CHMP's recommendation before announcing its final decision, which is expected in the third quarter of 2024.
Please note that Skyrizi is already approved in the United States and EU for treating plaque psoriasis, psoriatic arthritis and Crohn's disease. A potential approval for the UC indication will further expand the drug's label in the EU. UC is a type of chronic inflammatory bowel disease that affects the colon and rectum.
AbbVie has also submitted an application to the FDA, seeking the label expansion for Skyrizi to include the UC indication in the United States. The regulatory filing is yet to be accepted for review.
The stock rose 3.2% in response to the encouraging news. Year to date, shares of AbbVie have gained 4% compared with the industry's 16.3% growth.