This article is more than 5 years old. Information may no longer be current.
Janssen submits applications to FDA, EMA for approval of Stelara for Crohn's disease
Click Here to Manage Email Alerts
Janssen Biotech and Janssen-Cilag International have submitted a Biologics License Application to the FDA and a Grouped Type 2 Variation/Extension Application to the European Medicines Agency for approval of Stelara for the treatment of adults with moderate-to-severe active Crohn’s disease, the drugmaker announced.
Stelara (ustekinumab, Janssen), a human monoclonal antibody that targets interleukin-12 and -23 cytokines, is currently approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis in a number of countries, according to the press release. These same cytokines are thought to be involved in other immune-mediated diseases, including Crohn’s disease.
“At Janssen, we are committed to addressing the unmet medical needs of patients living with Crohn's disease through the discovery and development of innovative therapeutics,” Newman Yeilding, MD, head of immunology development at Janssen Research & Development, said in a press release. “We are pleased to submit applications seeking approval of Stelara for the treatment of moderately to severely active Crohn’s disease in the U.S. and in Europe, and we look forward to collaborating with health authorities throughout the review process.”
The submissions followed data from the UNITI studies, one of which (UNITI-2) showed ustekinumab was safe and effective for induction of clinical response and clinical remission. Data from the UNITI-1 and IM-UNITI trials will be presented at future medical congresses, according to the press release.
Disclosures: Yeilding reports he is an employee of Janssen.