Food and Drug Administration scientists are weighing the benefits and risks of a new Novartis drug that, if approved, would be the first pill to treat the symptoms of Multiple Sclerosis. According to regulators, the drug Gilenia appears to be an effective treatment for patients with relapsed MS, but its side effects include heart, lung and eye problems, as well as infections and skin cancer.
At least 8.5 percent of patients who took the drug experienced serious side effects, compared with only 5.8 percent of patients taking injectable drugs already on the market, the report said.
Reviewers also noted there was little data on long-term effects, and the drug’s impact on vulnerable patients with pre-existing conditions.
On Thursday, the FDA will meet with an outside panel of experts to discuss the risks of the new drug, and whether more studies are needed before approval.
The FDA plans to finish its review by September.
About 2.5 million people around the world suffer from the neurological disease, which can cause paralysis, memory and speech problems.


