Doctors Back Off Gilenya Amid Safety Woes

Doctors are backing off prescribing multiple sclerosis (MS) medication, Gilenya (gingolimod) amid a number of safety woes. Gilenya is manufactured by Novartis AG and received U.S. regulatory approval September 2010.

As we reported previously, Gilenya, the first approved MS pill, was under review by regulators in the U.S. and Europe. The U.S. Food and Drug Administration (FDA) review was announced last December after a patient died within 24 hours of taking his/her first dose of Gilenya. European Medicines Agency (EMA) regulators started their review last month, after receiving reports of 10 additional deaths among Gilenya patients. According to Novartis AG, six deaths were unexplained, three resulted from heart attacks, and one was due to disruption of heart rhythm.

The EMA said it expects its review to be completed by its March meeting next week. Its Committee for Medicinal Products for Human Use Committee is conducting the review, said Bloomberg News. “A role for Gilenya can neither be confirmed nor excluded at this time,” Novartis said concerning the U.S. Gilenya death, said Bloomberg News.

The deaths have “made me a little more cautious,” Aaron Miller, chief medical officer of the U.S. National Multiple Sclerosis Society and a medical director at New York’s Mount Sinai Hospital, told Bloomberg News. “I am not somebody who has recommended Gilenya as a first-line drug prior to these reports, and I’m still not recommending it as a first-line drug until we get more data,” Dr. Miller added. Miller treats about 800 patients and has prescribed Gilenya to about 30.

Timothy Vollmer, professor and director of clinical research in neurology at the University of Colorado in Denver, told Bloomberg News that he stopped using Gilenya in patients treated with older generation medications. “If they have any history of any kind of cardiac disease, we won’t consider the drug,” Vollmer said. “For older patients, we’re a little bit reluctant because of the cardiac issues,” he added.

About 10% of Gilenya patients have been taken off the drug following a thorough safety review, Vollmer noted. Novartis told Vollmer the clinic is one of the biggest U.S. Gilenya prescribers, said Bloomberg News. “We actually felt substantially let down by the company, because they knew about those things and they weren’t telling us about it,” Vollmer pointed out. “For us to use it the way we were using it we needed to feel that they were going to be quite forthcoming with all the safety information.”

A known side effect of Gilenya is brachycardia, or a slow heart rate; the FDA said heart rate usually returns to normal within 1 month after patients start taking the drug. European regulators advised doctors to increase patient monitoring after the first dose of Gilenya, including electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour. Patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved, they said.

Gilenya was approved for the treatment of relapsing-remitting MS and is used to reduce the frequency of MS flare-ups and delay physical disability. Since its approval, more than 30,000 people worldwide have taken Gilenya, said the FDA.

MS leads the immune system to attack the tissue that insulates nerve fibers, which stops those cells from sending signals. This fatigues patients’, blurs their vision, and causes deterioration in mobility, balance, and coordination, Bloomberg News explained. MS treatments are meant to assist the immune system, but there are side effects. Gilenya blocks white blood cells (lymphocytes) from circulating throughout the body, which stops them from reaching the brain, spinal cord, and optic nerves and prevents the cells from causing damage to these area.

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