Thursday, March 08, 2012

Novartis’s Gilenya and the Aftermath of a Safety Review

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The FDA and the European Medicines Agency are investigating 11 deaths among Gilenya patients.
Novartis said Dec. 12 that a U.S. patient had died within 24 hours of starting treatment with Gilenya, triggering reviews by the FDA and EMA, which reported a further 10 deaths among patients taking the medicine. Six of those deaths were unexplained, three patients died of heart attacks and one due to disruption of heart rhythm, the EMA said Jan. 20.

“A role for Gilenya can neither be confirmed nor excluded at this time,” Novartis said of the U.S. death.
The EMA’s Committee for Medicinal Products for Human Use has said it expects to complete its review by its March meeting, which is scheduled for next week.

Worldwide sales of MS immunomodulatory medicines exceeded $11 billion in 2010. The U.S. market was about $5.2 billion, according to Wolters Kluwer data, though that doesn’t account for rebates and discounts and may not include all U.S. sales. Weekly prescriptions for Gilenya have declined 1.5 percent since reaching a peak in December, according to the four-week average of Wolters Kluwer data analyzed by Bloomberg Industries.

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