FDA Approves Simponi for Ulcerative Colitis
Golimumab injection approved to treat adults with moderate-to-severe ulcerative colitis
WEDNESDAY, May 15 (HealthDay News) -- Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.
The drug is designed to block tumor necrosis factor, which has a key role in causing abnormal inflammation and immune system responses, the FDA said in a news release.
The drug has already been approved to treat psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis, the agency said.
Simponi was clinically evaluated in two studies involving more than 800 people. The most common side effects reported were upper respiratory infection and redness at the injection site. People treated with the drug are at greater-than-average risk of contracting several types of infection, lymphoma, heart failure, nervous system disorders, and allergic reactions, the FDA said.
The drug is marketed by Janssen Ortho Biotech Inc., based in Horsham, Pa.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352383.htm )