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 Novartis with a commanding lead in its race with Merck KGaA to get the first MS pill to the market, where it's expected to gain blockbuster revenue in competition with the injectables now available.

All 25 nervous system experts agreed that Gilenia is effective at reducing the frequency of relapses. By a 24 to 1 vote the panel also concluded that the therapy delayed physical disability among patients, controlling tremors and improving the concentration of patients as well as other symptoms of the disease.

The panel also concluded that the drug's safety profile was acceptable after hearing from senior FDA reviewer Lourdes Villalba. Villalba outlined a number of potential safety issues linked to the therapy, including a low heart rate, macular edema in the eyes and a slight drop in lung function. But the safety issues were not seen as a deal-breaker at the FDA, which also endorsed the need for more therapies to treat multiple sclerosis. Villalba specifically noted that the lower of two doses studied by Novartis had fewer side effects, and Novartis has already stated it intends to go with the low-dose version of Gilenia, which researchers say is about equally effective as the 1.25 mg dose that was also studied.

The FDA advisers were so intrigued by the combination of efficacy and improved safety at the lower dose that they recommended that the FDA require Novartis to mount a new trial to study an even lower dose, but agreed that the pharma company should be allowed to roll the therapy out now rather than wait years for more data.

- see Novartis' release
- read the story from Dow Jones
- here's the report from the AP 

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