The review, which will examine cardiovascular disruptions caused by the drug, may further cloud the prospects for a medication that had been expected to generate blockbuster sales for Novartis. Although a final review by the EMA is due in March, a growing number of deaths suggests the issue could become significant than had originally been thought.
The FDA approved Gilenya in 2010 as the first oral treatment for multiple sclerosis, and the EMA endorsed the drug last March. Novartis has been counting on Gilenya as to help compensate for the loss of patent protection on such big-selling drugs as the Diovan blood pressure pill. Meanwhile, competition in the MS market looms as Biogen Idec plans to seek FDA approval for an oral pill shortly.
“Increased alertness to toxicities is not what Novartis needs,” Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, tells Bloomberg News. “Will the tox profile become Gilenya’s Achilles heel?”
The risk of bradycardia after a first dose of Gilenya was known when the pill was approved, the EMA notes, but the cause of the first death is still unexplained. Among the other 10 patient deaths, six also remain unexplained, while three suffered heart attacks and another experienced a disruption of heart rhythms. About 30,000 people worldwide have taken Gilenya, according to the EMA.
[UPDATE: A Novartis spokeswoman sends us this statement: "Individual reports of cardiovascular and sudden unexplained deaths must be put into the context of the background rate of these incidents in the general population. Cardiovascular events are a leading cause of death in adults. Novartis takes patient safety very seriously. Based on our assessment of all the data in hand, it is the Novartis view that the benefit / risk profile of Gilenya remains favorable for eligible patients.”]
[UPDATE: In an investor note, Sanford Bernstein analyst Tim Anderson, who first reported the initial death, writes this: "Our best guess based on this information, and based on the dynamics in the MS category, is that Gilenya stays on the market but that regulatory agencies will make sure prescribers and patients alike better appreciate the potential harm that can be caused by the product...Naturally, the more warnings there are, the more the commercial outlook for Gilenya dims and as a newly-launched product that has seemed to have "blockbuster" potential, this is an understandable negative for investors."