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 weren't responding to other therapies (corticosteroids, Entyvio, etc.) or were intolerant to those therapies. The trial was divided into two phases: an induction phase and a maintenance phase. As their names suggest, the first is short-term and involves just one dosing, while the second involves multiple intravenous infusions over time. In the induction phase, significantly more people given the recommended dose (6 mg/kg) of Stelara than on placebo achieved a clinical response (62% vs. 31%) at week eight. Stelara treatment also significantly improved scores on the Inflammatory Bowel Disease Questionnaire (IBDQ), which assesses health-related quality of life for people with IBD. In the maintenance phase, after 44 weeks on the therapy, cl
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