A 59-year-old multiple sclerosis patient in the U.S died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease, according to several online news reports.
The patient, whose identity wasn’t revealed, had suffered for about a decade from multiple sclerosis, an autoimmune illness that affects the brain and spinal cord.
Erick Althoff, a spokesman for Novartis AG, which is based in Basel, Switzerland, said in an email to Bloomberg News that Gilenya’s involvement in the patient’s death can neither be excluded or 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 are taking Gilenya, said Bloomberg News.
Gilenya was approved in 2010. At the time, experts said that while the safety profile of the drug is acceptable, patients need to be aware the drug can lower the heart rate, provoke a small decline in lung function and cause eye problems.
According to Bloomberg News, Gilenya is one of several products that Novartis is hoping will increase sales as patents on other Novartis drugs begin to expire, including some of the company’s best selling key medications, such as Diovan.
Gilenya is one of Novartis’ most promising new drugs and has looked like becoming one of the leading treatments in the multibillion-dollar market for treating multiple sclerosis due to its easy use. Unlike traditional MS treatments that are given via infusions or injections, Gilenya is administered in pill form, the only one to date.
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.
Several analysts expect that because of the simple use of the drug, Gilenya could reach peak sales of more than $3 billion and grab almost a quarter of the $10 billion Multiple Sclerosis market. Pharmaceutical analyst Jack Scannell of brokerage Bernstein says that by 2015 it could reach around $1.5 billion in sales, up from $219 million reached after nine months in 2011.
But a safety issue could hurt the drug’s outlook.
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 since submitted details of the case to the Food and Drug Administration and other health authorities but that, as of yet, it hasn’t sent out a notification to doctors about a potential change in prescription needs. “Novartis takes patient safety very seriously and we are currently gathering all available details on this case,” it said.
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