FDA Expands Simponi Approval to Treat Ulcerative Colitis

The US Food and Drug Administration (FDA) today expanded approval of Simponi (golimumab) to treat moderate to severe ulcerative colitis, a chronic inflammatory bowel disease (IBD) that affects some 620,000 Americans.

Previously approved for other autoimmune diseases like rheumatoid arthritis (RA) and ankylosing spondylitis, Johnson & Johnson’s injectable Simponi blocks tumor necrosis factor (TNF), which plays a key role in causing abnormal immune system responses and inflammation. In ulcerative colitis, that inflammation in conjunction with ulcers in the inner lining of the large intestine can lead to abdominal discomfort, gastrointestinal bleeding, and diarrhea, the FDA said in a press release.

In a press release from J&J’s Janssen Ortho Biotech arm, William Sandborn, MD, of the Division of Gastroenterology at the University of California, San Diego School of Medicine and the lead investigator for Simponi’s clinical trials, said the drug’s new ulcerative colitis indication “represents a meaningful addition to the treatment armamentaria for gastroenterologists.”

“The FDA approval of Simponi brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis — a disease where treatment options have been limited,” Sandborn said.

In two Phase III, double-blind PURSUIT trials — which ultimately supported the drug’s expanded FDA approval — a greater proportion of the ulcerative colitis patients who were randomly assigned to subcutaneously injected 200-milligram or 100-milligram Simponi achieved clinical response, clinical remission, and improved endoscopic appearance of the colon after six weeks compared to the placebo group.

The most common side effects observed in the PURSUIT studies include upper respiratory infection and redness at the injection site. Simponi increases patients’ risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders, and allergic reactions — which are also listed in the drug’s safety profile in labeled rheumatologic indications, J&J said.