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Gilenya Sales Drop Following FDA Announcement

Filed March 7th, 2012 Laurie

As the Food and Drug Administration investigates the multiple sclerosis drug Gilenya in the wake of 11 deaths linked to it, the drug’s market share has declined, forcing analysts to cut their forecasts for peak sales.

Aaron Miller, chief medical officer of the U.S. National Multiple Sclerosis Society, and a medical director at Mount Sinai Hospital in New York. “I am not somebody who has recommended Gilenya as a first-line drug prior to these reports, and I’m still not recommending it as a first-line drug until we get more data.”

“Some uncertainty is to be expected in the marketplace as some physicians and patients wait for final review and potential label changes,” Novartis, the drug’s manufacturer, said. “Overall, we see Gilenya continuing to grow in volume. Gilenya potential is seen as unchanged.”

Eleven Gilenya patients have died taking the drug, including one who passed away within 24 hours of starting treatment. In the wake of an in-depth review of safety informaton, about 10 percent of patients have been taken off Gilenya.

Gilenya is prescribed to block white blood cells called lymphocytes from circulating in the body, preventing them from reaching and doing damage to the brain, spinal cord and optical nerves. It is the first MS pill on the market.

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