REMS Daily Archives
Novartis confirms that patient died within a day of initiating Gilenya treatment
Dec 13, 2011Novartis confirmed Monday that a patient with multiple sclerosis died within 24 hours of starting treatment with Gilenya (fingolimod). The drugmaker noted that "this is the first reported death event occurring within 24 hours of the first dose of Gilenya in more than 28,000 patients who have received Gilenya to date." Novartis added that "at this stage, the exact cause of death has not been established, and a role for Gilenya can neither be confirmed nor excluded at this time."
Novartis said that it has submitted details of the case to the FDA and other health authorities, but has yet to issue a notification to physicians about a potential change in prescription needs. "Novartis takes patient safety very seriously and we are currently gathering all available details on this case," the company said.
Sanford C. Bernstein analyst Jack Scannell said that the sudden death "smacks of being cardiovascular in nature," 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 is initiated. Scannell previously suggested that by 2015 the drug could reach approximately $1.5 billion in sales, up from $219 million in the first nine months of 2011. He noted that "with one death like the one we describe, it is not clear whether this will become a significant issue for Gilenya," but warned that "if [the] uptake of the drug were to falter—either because of new safety issues or because of intensified competition—it could dent sentiment on Novartis."
Gilenya garnered FDA approval in July 2010 as a first-line treatment for relapsing forms of multiple sclerosis. In March, the European Commission also approved the drug, marking the first oral MS treatment for use in the EU.
