Novartis adds details on heart safety and monitoring to label of its MS drug Gilenya

April 20, 2012 

NEW YORK (AP) — Swiss drugmaker Novartis AG said Friday it is updating the label on its oral multiple sclerosis drug Gilenya to help prevent heart problems.

The U.S. label now says that patients with some cardiac conditions, including heart attack or stroke in the last six months, should not take Gilenya. It says that all patients should have an electrocardiogram before they start using Gilenya, and they should have a second scan six hours after the first dose of the drug as well as addition to hourly monitoring of blood pressure and heart rate. Those steps are also recommended for patients whose treatment has been interrupted.

The label also says some patients with heart conditions or who are taking some other drugs should be monitored overnight after their first dose of Gilenya, and in some cases those patients should be evaluated before treatment.

Novartis is in talks with European Union regulators about other label changes, including warnings against using the drug in patients who are at risk for developing slow or abnormal heart rates.

Novartis said the U.S. label changes are the result of discussions with the Food and Drug Administration that began in December. The FDA approved Gilenya in September 2010 and European regulators approved the drug in early 2011. As of February, Novartis said approximately 36,000 patients had been treated with Gilenya in clinical trials and after the approval of the drug.

On April 13 Novartis said a patient who was taking Gilenya has been diagnosed with a potentially deadly brain inflammation. The patient developed a condition called progressive multifocal leukoencephalopathy, a rare infection that causes inflammation of the brain. There is currently no treatment or cure for PML, which can cause death or severe disability.

Novartis said the patient who developed PML had been using an older MS drug, Tysabri, for about three and a half years before starting treatment with Gilenya. The use of Tysabri is tightly controlled because it has been linked to PML, and Novartis said Tysabri was “the drug most likely associated with this case of PML,” but it cannot rule out the possibility that Gilenya contributed to the patient’s illness.

Novartis said it informed health authorities about the case, which was the first reported PML case in any patient using Gilenya. It said about 500 patients have been taking Gilenya for four years or more, and 2,400 have been treated for more than two years.