Multiple sclerosis drug Gilenya under investigation by FDA and EMA

By Dr. Ananya Mandal, MDJan 23 2012

The US Food and Drugs Administration (FDA) and European Medicines Agency (EMA) are looking at the pros and cons of using Gilenya (fingolimod) in treating the neurological autoimmune disease Multiple Sclerosis (MS).

The oral medication, developed and marketed by Novartis pharmaceuticals, competes with all other MS medications, including the Israeli-developed Copaxone and Rebif, which are injected by the patient on a daily basis. Gilenya, which was found to reduce the frequency and extent of neurological attacks, is a phospholipid, which captures lymphocytes in lymph nodes, thus preventing them from joining autoimmune attacks on nervous system.

The EMA is looking at a number of deaths that occurred not long after patients with relapsing remitting MS took the oral drug. There was one reported death in the United States of an MS patient who was taking fingolimod. There were also six other unexplained heart attacks deaths suspected of being connected to taking the oral drug. The agency advises doctors who have prescribed the drug to tell their MS patients who take Gilenya to report any side effects. Before patients start taking the drug they should undergo an electrocardiogram (EKG).

After taking the pill for the first time, the patient should be watched via EKG for six hours. Blood pressure and pulse should be taken hourly six times after the first pill is swallowed. If the patient suffers from brachycardia or other heart symptoms, the time the patient is directly observed could be extended, the ministry said. MS patients who have been prescribed Gilenya should report to the doctor immediately any heart problems such as chest pains, weakness or dizziness.

The Swiss drugmaker said last month it was investigating whether Gilenya, seen by analysts as a potential multibillion-dollar seller, caused the death of the 59-year-old U.S. patient.

Mark Schoenebaum, an analyst at ISI Group, said the call for active ECG monitoring was very different from the U.S. Food and Drug Administration (FDA) recommendation of observation and could encourage European doctors to use Biogen Idec's experimental BG-12. “We believe active ECG monitoring for six hours could be a material impediment to starting patients on Gilenya and could enhance BG-12's attractiveness to EU physicians once approved,” he said.

The FDA said on December 20 it was also looking into the U.S. case. Regulators on both sides of the Atlantic said the exact cause of the patient's death was still unexplained.

More than 30,000 people have received the drug worldwide. Multiple sclerosis affects 2.5 million people worldwide and is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.