The FDA has approved a third drug in as many years to treat multiple sclerosis (MS). On Monday, Teva Pharmaceutical Industries Ltd. said the agency had cleared Copaxone to be marketed in the U.S.
The news came as no surprise. In September, the Peripheral and Central Nervous System Drugs Advisory Committee unanimously agreed to recommend that the agency approve the drug, which is made up of synthetic polypeptides composed of four amino acids. (See BioWorld Today, Sept. 20, 1996, p. 1.)
Then in October, the FDA issued an approvable letter and notice of approval was expected by the year’s end. (See BioWorld Today, Oct. 8, 1996, p. 1.)
Teva, of Jerusalem, said the drug will be available in the U.S. early next year, but gave no specific date. It will be marketed by Teva Marion Partners, of Kansas City, Mo., a partnership between Teva and Hoechst Marion Roussel Inc.
Copaxone will compete with Avonex, made by Biogen Inc., of Cambridge, Mass., and Betaseron, made by Chiron Corp., of Emeryville, Calif.