FDA approves drug for Crohn’s, with caution

U.S. health officials approved Belgian drugmaker UCB Inc’s experimental drug to treat Crohn’s disease but warned about serious side effects, the U.S. Food and Drug Administration said on Tuesday.

The drug, called Cimzia, aims to treat adult patients with moderate to severe versions of the inflammatory bowel disease who have not responded to conventional treatments. More than 1 million people worldwide suffer from the chronic condition, according to the agency.

Regulators cautioned that the drug comes with significant risk including increased risk for “serious adverse effects, including serious infections that can lead to hospitalization or death,” the FDA said.

Symptoms of Crohn’s disease include diarrhea, fever, rectal bleeding, cramping and abdominal pain.

The drug, given as an injection, is one in a class known as tumor necrosis factor blocker drugs, which may cause lymphoma and other malignancies, it said.

Although no increased risk of tumors was seen in studies with Cimzia, those studies were short-term and UCB will be required to conduct further studies to determine the drug’s long-term safety, FDA said.

A spokesperson for the U.S. office of the Brussels-based company was not available for comment.

Common side effects reported with the drug include headache, upper respiratory infections, abdominal pain and nausea, the FDA said.