FDA to Review Stelara as Treatment for Crohn's Disease

Janssen is seeking FDA approval for ustekinumab (Stelara) as a Crohn’s disease treatment.

The FDA has accepted the manufacturer’s biologics license application, which contained phase 3 study data for the safety and efficacy of Stelara.

Stelara has already been approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in several countries.

The human IL-12 and IL-23 antagonist can be used alone or in combination with methotrexate to treat active psoriatic arthritis.

"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," said Newman Yeilding, head of immunology development at Janssen Research and Development, 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 US and in Europe, and we look forward to collaborating with health authorities throughout the review process."

Crohn’s disease affects around 700,000 Americans each year.