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 patients compared with placebo.

"These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS," says Trevor Mundel, global head of development at Novartis Pharma. "The data demonstrate the effectiveness of Gilenia irrespective of treatment history, and further support both the sustained efficacy of Gilenia over two years and the potential benefits of switching from interferon beta-1a, a currently approved MS therapy, to Gilenia."

Novartis has pulled ahead in the race to produce an oral MS drug. Merck KGaA hit a hurdle last November when FDA regulators handed back its application for cladribine, delaying any U.S. launch. Merck plans to refile as quickly as possible.

If approved, any oral MS drug is predicted to grab a sizable chunk of the $8.6 billion market. An oral drug would offer patients another option, as all treatments for the disease are currently injectable. On June 10, an advisory committee will meet to discuss Gilenia's safety and evaluate Novartis' proposed risk management program. "There have been a safety issue and some side effects, but the risk-benefit balance is still strongly in favour of Gilenia," one analyst tells Reuters.

- here's Novartis' release
- read this Reuters report for more