FDA approves thrice-weekly Copaxone

FDA approved an sNDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for a thrice-weekly 40 mg dose of multiple sclerosis (MS) drug Copaxone glatiramer acetate. Teva said the new dose will be available to patients "within days." The company already markets a once-daily 20 mg dose of Copaxone, but is set to lose exclusivity for that dose on May 24. During a presentation at the JPMorgan Healthcare Conference this month, Michael Hayden, Teva's president of global R&D and CSO, said the company expects to see up to 45% of patients who are receiving once-daily Copaxone switch to the thrice-weekly dose. Teva recorded U.S. Copaxone sales of $2.4 billion for the nine months ended Sept. 30 (see BioCentury Extra, Nov. 15, 2013). ...