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, clinical remission was achieved in 57.4% or 48.3% of people on Stelara, depending on how often injections were given (every 8 or 12 weeks, respectively). This was a significantly higher remission rate than that seen in the placebo group (35.4%).
Stelara was reported to have a favorable safety profile and be well-tolerated. Rates of adverse events and infections were similar in the Stelara and placebo groups during both trial phases.
“We welcome the CHMP’s positive opinion on ustekinumab, which brings us one step closer to making this important medicine available for people with ulcerative colitis in Europe, potentially offering them a chance of durable remission and symptomatic relief,” said Jaime Oliver, MD, Janssen Therapeutic Area Lead, Immunology, Europe, Middle East & Africa.