European and U.S. regulators are reviewing Novartis AG's Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.
The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it's also reviewing data on the medicine.
Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010. The FDA recommends that before patients start on the drug, they are made aware of potential heart-rate problems. The agency further recommends that patients only take Gilenya at their physician's office , where they are monitored for six hours after they take the first dose.
The Swiss pharmaceutical company Novartis says last November it was "notified of the first reported case of a patient death that occurred within 24 hours after receiving the first dose of Gilenya." In a statement to CNN, the company says the cause of death remains unknown. Ten more patients taking the medication have died, due to sudden death, heart attack or disruption of the heart rhythm, according to Novartis. "As noted by EMA, it is currently not clear whether these deaths were caused by Gilenya or not,"
The company points out that in clinical trials, there was not an imbalance in deaths of patients on the drug and incidents in the general population.
The National Multiple Sclerosis Society notes that it unclear what role Gilenya may have played in these deaths and is waiting for the results of the investigation. Dr. Timothy Coetzee, chief research officer for the National MS Society, says "understanding the benefits and risks of therapies is vitally important to everyone in the MS community."
In addition, the organization stresses the importance of the EMA's recommendation for heightened monitoring procedures after the first dose is administered.
The MS Society recommends patients currently taking this drug consult their doctor or contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) for more information.
The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it's also reviewing data on the medicine.
Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010. The FDA recommends that before patients start on the drug, they are made aware of potential heart-rate problems. The agency further recommends that patients only take Gilenya at their physician's office , where they are monitored for six hours after they take the first dose.
The Swiss pharmaceutical company Novartis says last November it was "notified of the first reported case of a patient death that occurred within 24 hours after receiving the first dose of Gilenya." In a statement to CNN, the company says the cause of death remains unknown. Ten more patients taking the medication have died, due to sudden death, heart attack or disruption of the heart rhythm, according to Novartis. "As noted by EMA, it is currently not clear whether these deaths were caused by Gilenya or not,"
The company points out that in clinical trials, there was not an imbalance in deaths of patients on the drug and incidents in the general population.
The National Multiple Sclerosis Society notes that it unclear what role Gilenya may have played in these deaths and is waiting for the results of the investigation. Dr. Timothy Coetzee, chief research officer for the National MS Society, says "understanding the benefits and risks of therapies is vitally important to everyone in the MS community."
In addition, the organization stresses the importance of the EMA's recommendation for heightened monitoring procedures after the first dose is administered.
The MS Society recommends patients currently taking this drug consult their doctor or contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) for more information.
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