Gilenia, a new once-daily pill created by Novartis for the treatment of multiple sclerosis (MS), was shown to reduce annual relapse rates by 62 percent in patients previously untreated, according to results from a two-year trial.
Relapse rates also decreased by 44 percent in patients taking Gilenia who had previously received other treatments. At the conclusion of the study, results also indicated that the progression of MS was slowed by 30 percent in patients taking Gilenia when compared to those taking a placebo.
"These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS," said Trevor Mundel, MD, head of Novartis' global drug development division.
Data from the study was presented at the annual meeting of the American Academy for Neurology.
Results from the study indicated that a 0.5 mg dose of Gilenia demonstrated the most favorable benefit, prompting Novartis to submit the dosage for regulatory approval in the United States and Europe. The company previously submitted applications for regulatory approval of Gilenia in December 2009.
Gilenia received priority review status from the U.S. Food and Drug Administration in February 2010. An advisory committee will meet to discuss the drug on June 10.
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