EMA Probes Novartis MS Pill Over Deaths

EMA Probes Novartis MS Pill Over Deaths

January 20th, 2012 // 3:27 pm @

One month after Novartis initiated an investigation into a death tied to its new Gilenya pill for multiple sclerosis, the European Medicines Agency has now launched its own probe after receiving reports of up to 11 deaths among patients who took the medication. This includes the first death that the drugmaker reported initially (here is the EMA statement).

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.


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