Novartis Gains Support for First Pill to Treat Multiple Sclerosis
Posted Jun 11 2010 12:00am
By Catherine Larkin
June 10 (Bloomberg) -- Novartis AG won a U.S. panel’s backing to introduce the first pill to treat multiple sclerosis as an alternative to injectable drugs led by Biogen Idec Inc.’s Avonex and Teva Pharmaceutical Industries Ltd.’s Copaxone.
Novartis’s Gilenia should be “generally recommended” as an initial treatment for MS, not just when other drugs fail, outside advisers to the Food and Drug Administration said in a 21-3 vote today in Silver Spring, Maryland. The panel voted unanimously in favor of the pill’s safety and effectiveness, while saying a lower dose should be tested after approval.
The Swiss drugmaker has been in a race with Merck KGaA to sell the first pill to delay progression of MS. The neurological disease affects 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group.
“This is an enormously effective drug,” said Cynthia Sitcov, the panel’s patient representative. “I hope the agency approves it at the current dose.”