Monday, January 22, 2007

FDA Approves Shire Drug For Ulcerative Colitis

The Food and Drug Administration has approved a new Shire PLC (SHPGY) drug to treat mild to moderate ulcerative colitis, the company said Tuesday.

The drug, Lialda, is a once-daily formulation of mesalamine, a drug commonly used to treat the condition.

Ulcerative colitis is a type of inflammatory bowel disease, a chronic condition that causes inflammation of the digestive tract. It's believed that about 500,000 Americans have ulcerative colitis.

Mike Yasick, Shire's senior vice president who oversees gastrointestinal drugs, said Lialda will offer much more convenient dosing than other mesalamine pills, which include another Shire drug, Pantasa. Those drugs require dosing three to four times daily and six to 16 pills.

A survey released last month by the Crohn's and Colitis Foundation of America found that 65% of patients with ulcerative colitis aren't compliant with their medication, which can make the disease more difficult to control.

Shire said Lialda would be available during the first quarter of this year.

More serious cases of ulcerative colitis are treated with steroids and other medications, such as Johnson and Johnson's (JNJ) Remicade, designed to block a protein involved with the inflammatory process.

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