An FDA advisory committee has given its unanimous blessing to the safety and effectiveness of the first oral medication for multiple sclerosis (MS). The panel also voted 21-3 that the same drug, called Gilenia, should be “generally recommended” as an initial treatment for MS. The FDA, which generally follows the advice of its advisory committees, is expected to approve the drug for market use by September. About 2.5 million people worldwide have MS.
Gilenia (0.5 milligrams) was found in clinical trials to reduce the relapse rate of the disease by about half. Currently, the numerous medications that treat MS must be injected. Gilenia specifically treats the relapsing forms of MS, but it could be used to treat people with the primary progressive form of the disease if future trials are successful.
It is believed that MS is caused by the body’s immune system “turning on itself,” which means white blood cells attack the myelin sheathes that protect nerve cells, which interrupts signals that control muscles. Gilenia is effective at keeping white blood cells stored in lymph nodes by taking away a chemical that helps release them. The major side effect with Gilenia, however, is an increase of infection. This is because the trapped white blood cells cannot fight infection.
Other side effects with Gilenia may include: an increase in liver enzymes, high blood pressure, bronchitis, swelling of the retina/impaired vision, and shortness of breath. Gilenia also slows the heartbeat in some patients, and the FDA is recommending that the first dose of Gilenia be administered under close medical supervision.
Despite these side effects, and the fact that drug manufacturer Novartis has been told by the FDA to perform clinical studies with lower doses (0.25 mg) after Gilenia potentially debuts on the market, the drug is generally considered to be safe and well-tolerated.
Medical experts say many MS patients are hesitant to begin or maintain treatment because current injectable medications are either ineffective, produce unwanted side effects, or cause discomfort when administered. Gilenia, they say, presents another potentially effective option that many patients would be much more willing to try.
Novartis was in competition with Merck to release the first oral medication for MS. Merck submitted paperwork to the FDA in November asking to sell cladribine, approved 10 years ago to treat leukemia, as a treatment for MS. The FDA said the initial paperwork was incomplete, and Merck has resubmitted.
Gilenia was initially created to prevent rejection in kidney transplant patients. The toxicity of the necessary dosage was too high, however, and the drug was found to be effective in treating MS in doses five times lower. Gilenia is still considered to be toxic at 0.5 mg, hence the reason the FDA wants it to be tested after market approval in doses of 0.25 mg.
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