The agency is not bound by the panel's decision, but generally follows its lead. Last June, the panel approved expanding access to Myotrophin under a special application that allowed the drug to be given away for free while its merits are debated. The two biotechs conducted two studies on the drug, one in the U.S. and a second one in Europe. Last year, two analysts questioned the European trial, saying it didn't confirm the U.S. results. An estimated 30,000 Americans suffer from ALS, a disease in which patients slowly lose muscular function.
Death often comes within five years of diagnosis.
The average age of onset of the disease is mid-50s. The only approved drug for ALS is Rhone-Poulenc Rorer's Rilutek. Another attempt to develop an ALS drug, one made by Regeneron Pharmaceuticals Inc., failed earlier this year. Inc. All Rights Reserved.