Simponi approved for ulcerative colitis

(HealthDay)—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 , which has a key role in causing abnormal inflammation and , the FDA said Wednesday in a news release.

The drug has already been approved to treat psoriatic arthritis, rheumatoid arthritis and , the agency said.

Ulcerative colitis, affecting some 620,000 Americans, causes chronic inflammation and ulcers in the inner lining of the large intestine. Common symptoms include abdominal discomfort, gastrointestinal bleeding and diarrhea.

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: Medline Plus has more about ulcerative colitis.

add to favorites email to friend print save as pdf

Related Stories

Xeljanz approved for rheumatoid arthritis

Nov 07, 2012

(HealthDay)—Xeljanz (tofacitinib) has been approved by the U.S. Food and Drug Administration to treat symptoms of rheumatoid arthritis (RA) among people who can't tolerate, or haven't been helped by, the drug methotrexate.

FDA approves Procysbi for nephropathic cystinosis

May 02, 2013

(HealthDay)—Procysbi (cysteamine bitartrate) delayed-release capsules have been approved by the U.S. Food and Drug Administration to treat nephropathic cystinosis in children (6 years and up) and adults. ...

Gattex approved for short bowel syndrome

Dec 22, 2012

(HealthDay)—Gattex (teduglutide) has been approved by the U.S. Food and Drug Administration to treat nutritional problems caused by short bowel syndrome.

Recommended for you

Study recalculates costs of combination vaccines

14 hours ago

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

18 hours ago

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

Pyridoxine-doxylamine drug safety data lacking

Apr 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

User comments