FDA approves Stelara for Crohn's disease
The FDA has approved Stelara for the treatment of adults with moderate-to-severe active Crohn’s disease for whom previous therapies have failed, the manufacturer announced.
Stelara (ustekinumab, Janssen) is the first biologic for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines.
William J. Sandborn
“Crohn’s disease is a complex condition to treat, and not all therapies work for every patient,” William J. Sandborn, MD, chief of the division of gastroenterology and professor of medicine at UC San Diego School of Medicine, said in a press release. “The FDA approval of Stelara represents an important advancement in treating patients with Crohn’s disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn’s disease.”
The approval was based on data from three phase 3 trials comprising more than 1,300 patients: the UNITI-1 and UNITI-2 induction trials, and the IM-UNITI maintenance trial. The induction trials showed Stelara induced clinical response and remission in patients with and without previous biologics treatment, with 34% of patients in UNITI-1 and 56% of patients in UNITI-2 experiencing symptom relief within 6 weeks of a single IV infusion, and some as early as 3 weeks. Moreover, most responders who received maintenance infusions every 8 weeks were in remission 52 weeks after their first induction dose.
Stelara is the only Crohn’s treatment that begins with a weight-based IV infusion for induction followed by a 90 mg subcutaneous maintenance injection every 8 weeks, according to the press release.
Janssen said it will work with payers, providers and pharmacies to ensure Stelara is accessible and affordable, and that the cost for payers is competitive. The company offers several patient support programs, including a co-pay card to reduce patient out-of-pocket costs.
Disclosures: Sandborn reports financial relationships with Janssen.