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FDA Approves 1st Oral Drug to Reduce MS Relapses
Date:9/22/2010

ic relapses, according to the multiple sclerosis society.

Until now, the existing treatments for reducing relapses in relapsing MS were all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they're started early in the course of the disease, so he's hoping that having oral medications will help people start treatment sooner.

The two Gilenya studies published in January were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.

Annual relapse rates were less than 1 percent each year, and 54 percent less for the lower dose of Gilenya and 60 percent for the higher dose. The study also found slower disease activity and progression.

In the second study, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of Gilenya or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on Gilenya had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.

Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking Gilenya.

Novartis said Wednesday that the FDA approved a 0.5-milligram daily dose of Gilenya.

More information

To learn more, visit the National Multiple Sclerosis Society.

SOURCES: Sept. 22, 2010, news release, U.S. Food and
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