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EMA recommends approval of Stelara for Crohn's disease
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The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending marketing authorization in the European Union for Stelara in patients with moderate-to-severe active Crohn’s disease for whom other therapies have failed, according to a press release.
If approved, Stelara (ustekinumab, Janssen) would be the first interleukin-12/23 inhibitor for 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 the press release. “Ustekinumab has shown clinical benefit, is generally well tolerated, and has a convenient dosing regimen for people living with Crohn’s disease who are eligible for a biologic therapy.”
The EMA’s positive opinion is based on data from three phase 3 studies — UNITI-1, UNITI-2 and IM-UNITI — involving an estimated 1,400 patients with Crohn’s disease in total. The induction studies showed ustekinumab resulted in significantly greater rates of clinical response at week 6 compared with placebo, and the maintenance study showed significantly greater rates of clinical remission at week 44. The drug was generally well tolerated and showed a safety profile consistent with current labeled indications.
A final decision on approval is expected later this year, according to the press release. Janssen is also seeking approval for ustekinumab for moderate-to-severe active Crohn’s disease in the U.S.
Disclosures: Lavie is employed by Janssen.