Posted by Michael Wonder on 29 Jul 2019
Janssen receives CHMP positive opinion for Stelara (ustekinumab) recommending approval for the treatment of moderately to severely active ulcerative colitis in the EU
26 July 2019 - If approved, ustekinumab will be the first interleukin (IL)-12/23 inhibitor licensed for ulcerative colitis.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation in the European Union (EU) for the use of ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
The CHMP adopted the opinion based on data from the pivotal Phase 3 UNIFI trial programme which demonstrated ustekinumab’s efficacy as a treatment option for patients with moderately to severely active UC who demonstrated an inadequate response to or were unable to tolerate conventional (e.g. corticosteroids or immunomodulators) or biologic (tumour necrosis factor [TNF]-alpha antagonists or vedolizumab) therapies.
