First Multiple Sclerosis Drug Nears FDA Approval
Advisers to the Food and Drug Administration (FDA) voted in favor of recommending a medicine by Novartis AG to treat multiple sclerosis (MS).
The drug, known as Gilenia, will become the first pill to treat MS if ever approved by the FDA. The FDA normally follows the adviser panel, though they are not required to do so. FDA will decide the approval of Gilenia this coming September. The panel declared Gilenia as “generally recommended.”
Novartis is facing competition with Merck KGaA in producing the first pill for MS.
Currently patients with MS have invasive, injectable medications as their limited option.
About 2.5 million people worldwide are affected by the neurological disease. Problems with current therapies are that they’re difficult to use or have side effects.
Injectable drugs currently available are Biogen Idec Inc.’s Avonex, Merck KGaA’s Rebif and Teva Pharmaceutical Industries Ltd.’s Copaxone. Novartis said that some people couldn’t tolerate these drugs.