Drug Watchdog Calls on FDA to Restrict Gilenya MS Drug

A drug watchdog has called on the U.S. Food & Drug Administration (FDA) to restrict multiple sclerosis drug, Gilenya, following patient deaths.

We recently wrote that doctors were backing off prescribing multiple sclerosis (MS) medication, Gilenya (gingolimod) amid a number of safety woes. Manufactured by Novartis AG, Gilenya 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 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 in February, 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. Pharmalot wrote that Novartis began its investigation of the death tied to Gilenya four months ago and was followed by the FDA and, then, the EMA probes.

Most recently, the Institute for Safe Medication Practices (ISMP) called for the FDA to restrict use of the drug and improve its patient monitoring. The ISMP based its request on a review of adverse events reported to the FDA in the second quarter of last year. “Problems of widespread toxicity that were already evident in clinical testing of (Gilenya) are now producing strong signals in the post-market adverse event data,” ISMP wrote in its most recent Quarter Watch report on drug safety.

Of 286 reports, 60 involved retinal injuries and other adverse vision effects; 68 involved infection reports at various areas of the body, eye, skin, urinary tract, and upper respiratory tracts; and a number of vascular-related adverse effects including 16 blackouts or syncope, 27 reductions in blood pressure, slow heart rate, or bradycardia, and 10 cases of peripheral edema, said Pharmalot.

ISMP acknowledged that Gilenya, the first MS pill, provides advantages and offers a new mechanism of actions; however, it also pointed out that clinical testing prior to FDA approval “revealed a troubling safety profile that might have halted the development of drugs for many other disorders with a less serious long-term prognosis,” Pharmalot reported. ISMP discussed, in particular, a decision made by Novartis to discontinue a 1.25 mg dose over very serious adverse events, including two deaths from opportunistic herpes infections, a rare and fatal MS deterioration, and six vascular events. The clinical trial arm focused on the 1.25 mg dose was terminated for safety reasons; Novartis only sought approval of a 0.5 mg dose, said Pharmalot.

Despite this and even though data provided to the FDA revealed a number of serious side effects—birth defects in typical animal screening studies; herpes infections; lower respiratory tract infections, as well as unusual ear, sinus, and eye infections; and two deaths—the agency agreed to fast track the drug’s approval schedule

Pharmalot pointed out that 8% of patients prescribed the recommended dose of Gilenya tested with evidence of liver damage; routine liver testing is not recommended for patients taking the drug. Also, trials before approval included three cancer deaths in which the FDA was not able to rule out Gilenya as a potential culprit.

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. 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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