FDA Launches Gilenya Safety Review Following Patient Death

The U.S. Food & Drug Administration (FDA) is launching a Gilenya safety review after having recently receiving a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking his/her first dose of Gilenya (fingolimod). The patient died on November 23.

Gilenya is a 0.5 mg oral capsule prescribed for the treatment of relapsing forms of MS in adults and is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability. Gilenya is the first pill approved by the FDA for the treatment of MS, a devastating neurological disease.

The FDA said it is unable to conclude whether Gilenya, manufactured by Novartis AG, caused the patient’s death but continues to evaluate the case. The agency also said that it believes that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA also said that patients with MS should not stop taking Gilenya without speaking with their healthcare professional.

Gilenya may cause serious side effects that include bradycardia (slow heart rate), which may be related to slowed conduction of electrical impulses from the heart’s upper chambers to its lower chambers. These effects generally do not manifest with symptoms; however, when they do, patients can experiences dizziness, fatigue, and palpitations. Typically, heart rate slowing as a result of taking Gilenya usually happens after the first dose, with the heart rate returning to normal within one month.

Erick Althoff, a Novartis AG spokesman, said in a prior email to Bloomberg News that Gilenya’s involvement in the patient’s death can neither be excluded nor confirmed. This fatality is the first reported death that has occurred within 24 hours of a patient taking his/her first dose of Gilenya, said Althoff, who added that 28,000 patients take Gilenya.

Gilenya was approved in the U.S. in 2010 and was cleared to be sold in Europe earlier this year and is one of several products that Novartis is hoping will increase sales as patents on other Novartis drugs begin to expire, including some key medications. “In the case of MS drugs, there is often significant safety baggage of different sorts,” Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors, said Bloomberg News previously.

The patient’s specific cause of the death has not yet been determined, said Novartis; however, sudden death “smacks of being cardiovascular in nature,” wrote Anderson, said Bloomberg News. Anderson added that the potential for a temporary slowdown in heart rate after patients begin Gilenya treatment is one reason a recommendation is called for to monitor Gilenya patients in a doctor’s office as soon as treatment begins.

The patient who died started treatment November 22 and was monitored “without incident” for six hours following the first dose. Novartis said it provided the case’s details to the FDA and other regulatory authorities.

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