Novartis Confirms Patient Died After Starting Gilenya (fingolimod)

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

“In the case of MS drugs, there is often significant safety baggage of different sorts,” Anderson wrote. He rates Novartis’s shares “outperform” and estimates that by 2015 Gilenya sales will reach $1.4 billion, about 2 percent of the Swiss company’s revenue.

The exact cause of the death hasn’t been established, Novartis said. Sudden death “smacks of being cardiovascular in nature,” Anderson wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.

The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.

Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.

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source: Bloomberg.com (Kresge, 12/13)



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