Biogen and Elan won US approval last night to market their drug Tysabri for treating the bowel disorder Crohn's disease.
The drug already is sold for multiple sclerosis with tight restrictions and a strong warning about a potentially fatal brain infection. The companies must put similar limits on sales for Crohn's disease, the Food and Drug Administration (FDA) said.
Crohn's disease is a bowel inflammation that can cause disabling abdominal pain, weight loss, fever and rectal bleeding. An estimated 500,000 people in the United States have Crohn's disease, Elan said.
The FDA approved Tysabri for adults with moderate to severe Crohn's disease who have evidence of inflammation and have a poor response to, or cannot take, other therapies.
Tysabri is an important step in treating Crohn's but one that carries serious risks, said Dr Joyce Korvick of the FDA.
European regulators have recommended against use of Tysabri for Crohn's disease, and Biogen and Elan expect a final decision from the European Commission during the first quarter of 2008.
At 9.15am Elan shares were marginally down at €16.77, off 2 cent.