CHMP Favors Approving Stelara to Treat Moderate to Severe Ulcerative Colitis in EU

CHMP Favors Approving Stelara to Treat Moderate to Severe Ulcerative Colitis in EU
The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has recommended that Stelara (ustekinumab) be approved in Europe to treat moderately to severely active ulcerative colitis (UC) in cases where other therapies aren't working. Janssen Pharmaceuticals, Stelara's developer and a part of Johnson & Johnson, announced CHMP's positive opinion in a press release. A final decision by the European Commission is expected later this year. Stelara works by blocking two inflammatory signaling proteins: interleukin (IL)-12 and IL-23, important targets in treating UC. It is currently approved to treat moderate to severe Crohn's disease, as well as plaque psoriasis, in both Europe and the United States. A similar request for U.S. approval for ulcerative colitis patients was submitted to the FDA in December. The CHMP recommendation is based largely on data from the Phase 3 UNIFI clinical trial (NCT02407236), which tested Stelara in people with moderately to severely active UC who we
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