FDA panel hands Novartis lopsided endorsement of oral MS therapy

An FDA advisory panel has handed Novartis a big win, voting overwhelmingly to endorse the efficacy and safety of its new oral MS drug Gilenia (fingolimod). The only serious hitch today came on the safety side, with the experts backing a proposal to have Novartis study an even lower-dose version of the drug than had been under the microscope in late-stage studies. But the advisers agreed that the new study could commence after Novartis began marketing the therapy. The vote in its favor leaves...

Merck KGaA resubmits oral MS drug to FDA

Seven months after the FDA sent Merck KGaA back to the drawing board for new work on its application for the oral MS drug cladribine, the German pharma company says it has resubmitted the closely watched therapy for an approval. The agency had rejected Merck's original application, but the pharma company declined to say exactly what the FDA wanted them to do to fix it. Several analysts believe that the therapy is an odds-on favorite for approval. Novartis, meanwhile, will present its oral MS...

Novartis unveils more positive data for oral MS drug Gilenia

Novartis is touting more positive data for Gilenia (FTY720), the company's late-stage oral multiple sclerosis drug. The data, which were presented at the American Academy of Neurology meeting, demonstrated that Gilenia prevented relapse in 62 percent of treatment-naïve patients, while relapse rates were reduced by 44 percent in those who'd already received other treatments. In addition, at two years, Gilenia delayed the progression of disability by 30 percent for...