Novartis Confirms Patient Died After Starting Gilenya Drug
December 12, 2011, 1:36 PM EST
By Naomi Kresge
(Updates with analyst comment starting in third paragraph.)
Dec. 12 (Bloomberg) -- Novartis AG said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.
Gilenya's role in the patient’s death can’t be excluded , Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.
Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.
Novartis said. Sudden death “smacks of being cardiovascular in nature,” Scannell wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.
The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.
Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.
December 12, 2011, 1:36 PM EST
By Naomi Kresge
(Updates with analyst comment starting in third paragraph.)
Dec. 12 (Bloomberg) -- Novartis AG said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.
Gilenya's role in the patient’s death can’t be excluded , Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.
Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.
Novartis said. Sudden death “smacks of being cardiovascular in nature,” Scannell wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.
The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.
Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.