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FDA on Novartis new multiple sclerosis drug -- safe & effective

By Joan Firstenberg     Jun 11, 2010 in Health
Silver Spring - Finally the U.S. Food and Drug Administration has approved a pill that it says is both safe and effective for controlling tremors and other symptoms of multiple sclerosis.
The drug, Gileria by Swiss drugmaker, Novartis is a first-of-a-kind treatment for the debilitating effects of multiple sclerosis. The Huffington Post
reports that Gileria is the first pill ever for MS sufferers, who previously have had only drugs that had to be delivered by injection or infusion, and many had flu-like side effects.
The FDA panelists did warn that the drug's side effects will require screening to make sure patients are healthy enough to receive the treatment. The panel voted 25-0, deciding that Gilenia helps reduce relapses of multiple sclerosis, which causes of host of movement and cognitive problems. In a separate vote the panel said unanimously that the proposed dose of the drug appears safe.
Despite the overwhelming approval, the FDA panel still had questions about Gilenia's side effects, which include eye disorders, heart problems and weakened lung function. Doctors say these side effects are less likely to appear with a lower dose of the Novartis drug.
The FDA is taking a look at the drug under a priority timetable reserved for promising new therapies. A decision is expected by late September.
There are about 2.3 million people worldwide who suffer from multiple sclerosis. Patients usually feel well for a period of time, then periodically relapse.
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