FDA Approves New Indication for Simponi (original) (raw)

The US Food and Drug Administration (FDA) today approved a new indication for the tumor necrosis factor (TNF)-alpha inhibitor golimumab (Simponi, Janssen Biotech): treatment of adults with moderate to severe ulcerative colitis that is resistant to prior treatment or requires continuous steroid therapy.

Golimumab is also approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis, and active ankylosing spondylitis.

For the treatment of ulcerative colitis, the golimumab dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2, and then 100 mg every 4 weeks, thereafter, the company said.

"Important" New Option

Golimumab is "an important new treatment option for patients with moderate to severe ulcerative colitis," Andrew E. Mulberg, MD, deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"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," Dr. Mulberg added.

Ulcerative colitis is a chronic disease that affects about 620,000 individuals in the United States. It causes inflammation and ulcers in the inner lining of the large intestine and is 1 of 2 main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus, and diarrhea.

According to the FDA, the safety and effectiveness of golimumab for ulcerative colitis were established in 2 placebo-controlled clinical studies.

In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive golimumab or placebo. The results showed that a greater proportion of golimumab-treated patients achieved clinical response, clinical remission, and, as seen during endoscopy, had improved appearance of the colon after 6 weeks compared with the placebo group.

In the second study, 310 patients with moderate to severe ulcerative colitis who had previously responded to golimumab were randomly assigned to receive golimumab or placebo. In this study, a greater proportion of golimumab-treated patients maintained clinical response through week 54, had clinical remission at both weeks 30 and 54, and, as seen during endoscopy, had improved appearance of the colon at both weeks 30 and 54 compared with the placebo group.

The most common adverse effects seen with golimumab are upper respiratory infection and redness at the site of injection. Patients treated with golimumab are at increased risk of developing serious infections, invasive fungal infections, reactivation of hepatitis B virus infection, lymphoma, heart failure, nervous system disorders, and allergic reactions.

The FDA approval of golimumab "brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited," William Sandborn, MD, director of the University of California San Diego Inflammatory Bowel Disease Center, and lead study investigator, said in a statement from Janssen Biotech.

Golimumab "represents a meaningful addition to the treatment armamentaria for gastroenterologists," he added.