FDA approves alternative treatment for Crohn’s disease

A new treatment for Crohn’s disease was approved by the FDA this week, one that aims to serve as an alternative for patients who are intolerant of immunomodulators or corticosteroids.

The drug Stelara, made by Janssen Biotech, is the first biologic therapy for Crohn’s disease and will target interleukin (IL)-12 and IL-23 cytokines, which dictate inflammatory and immune responses in the gastrointestinal tract, the company said in a statement.

It is a weight-based, one-time intravenous infusion induction dose with maintenance injections every eight weeks.

Stelara was tested in clinical trials led by William J. Sandborn, MD, the chief of gastroenterology and a professor of medicine at UC San Diego School of Medicine. In the studies, researchers examined Stelara’s effect on more than 1,300 patients. Results showed 34 to 56 percent of patients received relief from their Crohn’s disease symptoms within six weeks of receiving the medication, with improvement being detected in the first three weeks. Those who continued with dosing every eight weeks were in remission by 52 weeks after the induction dose.

"Crohn's disease is a complex condition to treat, and not all therapies work for every patient," Sandborn said in a statement. "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."

Janssen said they are working to make Stelara affordable and competitive with other products like it, hoping to establish a copay of no more than $5 per dose for patients with commercial insurance.