MS Drug Reaffirms Effectiveness in Clinical Trial

Gilenya treatment success comes on heels of safety concerns

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Gilenya, a FDA-approved multiple sclerosis drug, had positive results in a late-stage clinical trial. The results may help ease safety concerns about the drug.

In the Phase III trial, patients who took Gilenya were 48 percent less likely to suffer a relapse attack than patients who did not take the drug. The study's findings were announced days after the drug's maker, Novartis, said that it was investigating Gilenya's role in the death of a man who had just begun therapy with the drug.

"Gilenya is safe and effective for most patients. Ask your doctor about it."

The study, sponsored by Novartis, was done to provide safety information requested by the FDA application process. The drug was approved in 2010.

Gilenya is the first once-daily pill for treating multiple sclerosis (MS). It works by lowering the number of a type of white blood cell called lymphocytes, which are thought to attack the protective sheath of nerve cells in the brain. According to the company's website, how Gilenya works in MS is not exactly known. But it's suspected that Gilenya acts to keep the lymphocytes in the lymph nodes, rather than releasing them to attack the nervous system.

The study may ease the safety concerns that were stirred up after a 59 year-old man died in November, just a day after taking his first dose of Gilenya. The death is the first reported among 28,000 who have taken the drug, said a Novartis representative.

The drug has been through multiple clinical trials. This is the third Phase III trial showing a reduction of relapse rates in patients with relapsing-remitting MS, one of the most common forms of MS. Dr. Peter Calabresi, a Professor of Neurology at Johns Hopkins University said that this study confirmed the effectiveness of the drug, seen in the previous trials.

The study enrolled 1083 patients across the US. Participants either took Gilenya or a placebo. At the end of the 24-month trial, the group that had taken Gilenya had a 48 percent reduction in annual relapse rates. They also saw a reduction in brain volume loss. That means the disease had less of an effect on the brain. Brain volume loss is a predictor for long-term disability in MS.

There were no deaths during the trial, Novartis reported.

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Review Date: 
December 19, 2011
Last Updated:
October 21, 2012