Novartis has confirmed that a patient who had just started treatment with its multiple sclerosis pill Gilenya has died.
The Swiss major noted that he began treatment with Gilenya (fingolimod) on November 22 and had been monitored without incident for six hours after taking the first dose. He passed away the day after.
Novartis said this is the first reported death occurring within 24 hours of the first dose of Gilenya in more than 28,000 patients who have received the pill to date." The company 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."
The company has submitted details of the case to regulators and said that it "takes patient safety very seriously and we are currently gathering all available details on this case".
Jack Scannell, an analyst at Sanford Bernstein, issued a research note, saying that "in the case of MS drugs, there is often significant safety baggage of different sorts". He added that the sudden death “smacks of being cardiovascular in nature”, arguing that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is one of the reasons why it is recommended for monitoring in a doctor’s office after treatment begins.