US FDA approves Janssen's Simponi to treat ulcerative colitis

The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Ortho Biotech’s Simponi (golimumab) injection, to treat adults with moderate to severe ulcerative colitis.

Simponi, a biologic already approved to treat adults with moderate-to-severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, generated first-quarter sales of $237 million (up 104% year-on-year) for J&J, the drug is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.

“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew Mulberg, deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently,” he noted.