Data Reinforces Efficacy and Safety of Novartis Multiple Sclerosis Drug
- Mon, 10/15/12 - 9:21am
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Novartis announced a post hoc analysis of two phase 3 trials found patients who took 5 mg of Gilenya (fingolimod) experienced significant improvement in relapse-related outcomes within three months of treatment and brain volume loss by the sixth month. In addition, an updated safety analysis of 3553 patients confirmed the drug's safety profile.
Results were presented at last week's European Committee for Treatment and Research in Multiple Sclerosis in Lyon, France.
In September 2010, fingolimod became the first FDA-approved oral drug to treat multiple sclerosis. The FDA last month approved Aubagio (teriflunomide) as the second oral MS drug, and it is expected to approve a third oral drug (BG-12 from Biogen Idec) later this year.
In its news release, Novartis noted that as of August 2012, more than 49,000 patients had been treated with fingolimod.
More information on fingolimod's updated data is available here.