Elan Corp and Biogen Idec have failed in their appeal to get a positive recommendation from Europe’s regulators for Tysabri to be approved as a treatment for Crohn’s disease.
The Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has once again adopted a negative opinion on the marketing authorisation for Tysabri, which is approved as a treatment for multiple sclerosis. The decision comes after an appeal the companies filed following a previous thumbs-down by the CHMP in 2007.
Elan and Biogen restricted themselves to noting that this negative opinion is now referred to the European Commission and they acknowledge that “final EC decisions customarily follow the CHMP’s recommendation”.
The news is a blow to the two firms, especially as a joint meeting of the US Food and Drug Administration’s Gastrointestinal Drugs Drug Safety and Risk Management Advisory Committee voted 12 to three in August to back Tysabri in Crohn’s disease. In the MS indication the drug is selling well, and third-quarter sales reached $93.3 million,
Tysabri only returned to the market in July 2006 after being pulled off on safety concerns in February 2005, and its reintroduction came with restrictions to monitor patients for symptoms of the rare brain disease progressive multifocal leukoencephalopathy.
