An advisory committee to European drug regulators is recommending that Tysabri, the multiple sclerosis drug from
, be returned to the market.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on the drug, Biogen and Elan said in a press release Friday. The panel arrived at its decision after reviewing data from clinical trials and the results of safety analyses that were performed after Tysabri was linked to a potentially fatal brain disease.
The committee specifically suggested that Tysabri should be used to treat recurring MS in order to delay the progression of the disease. The recommendation will be considered when the European Commission decides whether to grant final marketing approval for the drug, which the companies anticipate this summer.
Tysabri was recalled last year after two cases of a rare brain illness, progressive multifocal leukoencephalopathy, were discovered in people who had taken the drug along with another product designed to suppress the body's immune system. A third case involving Tysabri and an immune-system suppressant was later found.
Early last month, an advisory panel to the U.S. Food and Drug Administration also
recommended that Tysabri again be cleared for sale. An FDA decision is expected in June.
Shares of Biogen, Cambridge, Mass., were up 67 cents, or 1.5%, to $45.63. Elan was gaining 30 cents, or 2.1%, to $14.76.