) says its late-stage multiple sclerosis drug, Gilenia, slows the disability's progression and reduces annual relapse rates, bolstering its lead in the race to be first to reach the $8.6 billion MS treatment market with an oral MS treatment. The new data pushes Gilenia even further ahead of cladribine, Merck’s (MRK
) horse in the oral MS treatment competition, which was bounced back by the FDA in November 2009 after the agency said its application was incomplete.
The agency has scheduled Gilenia for priority review, a status granted to investigational drugs that may offer significant advances beyond current treatments or where no adequate therapy exists. Leading interferon-based therapies now include Biogen Idec's (BIIB
) Avonex and Bayer's Betaferon/Betaseron, both of which are administered by injection.
The FDA has scheduled an advisory panel review of Gilenia for June 10. Among that panel's considerations will be an analysis of data showing that both Gilenia and cladribine have been shown to suppress the human immune system, potentially leaving patients open to higher rates of infection than they would have encountered during interferon-based treatments.
Novartis’ latest data shows that Gilenia, also known as FTY720, reduced annual relapse rates by 62 percent in newly treated patients compared to a placebo, and by 44 percent in people who had previously received other treatments. The study was presented April 20 at the American Academy of Neurology meeting in Toronto.
Trevor Mundel, Novartis' global head of development, says that the findings “reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS” and that they “demonstrate the effectiveness of Gilenia irrespective of treatment history” and “the potential benefits of switching from interferon beta-1a, a currently approved MS therapy, to Gilenia.”
“Having oral therapies in the MS pipeline is real progress, and it should increase the number of people who choose to begin therapy earlier and who stay on therapy, which our experts say is the best way to combat future disease activity,” says John Richert, executive vice president of research and clinical programs at the National MS Society, who spoke on the importance of the drugs in January.