UPDATE 2-U.S. FDA approves UCB bowel drug, with caution

Last Updated: 2008-04-22 15:39:17 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. health officials on Tuesday approved Belgian drugmaker UCB Inc's (UCB.BR: Quote, Profile, Research) experimental drug to treat Crohn's disease, but they warned of serious potential side effects.

The U.S. Food and Drug Administration said it approved the drug, called Cimzia, 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. Symptoms of Crohn's disease include diarrhea, fever, rectal bleeding, cramping and abdominal pain.

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

Rival Abbott Laboratories (ABT.N: Quote, Profile, Research) sells a drug to treat Crohn's disease called Humira, which carries similar warnings about risk of malignancies and fatalities.

UCB needs potential new blockbusters after expiration of patent protection on allergy medicine Zyrtec last year. Keppra, its epilepsy drug, is set to lose its protection in 2009.

The company had hoped to gain approval for Cimzia in Crohn's early last year, but announced in December 2006 that the FDA had required additional information. The start of a new trial, and the subsequent failure to gain approval for Cimzia in Europe, sparked a sharp fall in UCB's share price.

Some analysts had even questioned whether Cimzia would ever get to market or, if it did, that it would be far behind its competitors.

A company spokeswoman said the company aimed to treat its first patient within 48 hours.

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.

The most common side effects reported with the drug include headache, upper respiratory infections, abdominal pain and nausea, the FDA said. (Reporting by Susan Heavey and Kim Dixon in Washington and Philip Blenkinsop in Brussels; Editing by Braden Reddall, Richard Chang)