The Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency (EMA), has issued a positive opinion on Janssen’s Stelara (ustekinumab) for the treatment of patients with moderate-to-severe active Crohn’s disease, and for whom other therapies have failed.
The European Commission (EC) now will review CHMP’s opinion, with a final decision concerning marketing authorization for Stelara expected later this year. If the EC grants approval, Stelara will be marketed in the European Union and will be the first interleukin-12/23 inhibitor approved for Crohn’s disease.
Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23 molecules, currently approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis in a number of countries. These same cytokines are believed to play a role in the autoimmunity that leads to disorders such as Crohn’s disease.
“Crohn’s disease is a debilitating chronic condition that has a huge impact on patients’ quality of life. Patients experience unpredictable disease flares and many have lost response to currently available treatments, so it is vital that new therapeutic options are made available to help control their symptoms,” Frederic Lavie, Janssen’s EMEA therapeutic area leader in immunology, cardiovascular and metabolics, said in a press release. “Ustekinumab has shown clinical benefit, is generally well tolerated, and has a convenient dosing regimen for people living with Crohn’s disease (and) who are eligible for a biologic therapy,” he said.
EMA’s positive opinion is based on data from a comprehensive Phase 3 UNITI clinical program, which included three studies: UNITI-1, UNITI-2 and IM-UNITI involving 1,400 patients with Crohn’s disease. The results of this comprehensive Phase 3 program demonstrated the potential of Stelara to provide significant benefit for patients in need of an effective therapy.
In the induction Phase 2 studies (UNITI-1 and UNITI-2) treatment with Stelara led to greater rates of clinical response at week 6 compared with placebo in Crohn’s disease patients who had failed conventional therapy, but were mostly naive to treatment with anti-TNF-alpha.
In the IM-UNITI maintenance study investigating clinical remission effects in patients with moderate to severe Crohn’s disease, the results showed that a significantly greater proportion of patients receiving Stelara subcutaneous (SC) maintenance therapy were in clinical remission after 44 weeks when compared to those on placebo. Clinical remission, the study’s primary endpoint, was defined by a Crohn’s Disease Activity Index (CDAI) score of less than 150 points. The therapy was generally well-tolerated and showed a safety profile consistent with current labeled indications.