Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths

European and U.S. regulators are reviewing Novartis AG’s (NOVN) 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.

Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.

“In my view this is highly unlikely to be related to the drug, but of course they have to check that,” Karl Heinz Koch, an analyst at Helvea SA in Zurich, said in a telephone interview today. “With all the experience we have with the drug, my comfort level is relatively high, but you can never be 100 percent sure. It certainly doesn’t help the share price.”

Novartis fell 3.9 percent to 52.05 Swiss francs in Zurich trading, the biggest decline since Aug. 10.

‘Possible Label Changes’

“We have been in touch with EMA, and similar to what they are doing, the FDA is conducting an analysis of available data and has not made any definitive conclusions,” Erica Jefferson, a spokeswoman for the U.S. regulator, said in an e-mail. “We will notify the public once our review is complete to communicate any recommendations or possible label changes.”

Novartis said it’s working with the EMA on the review and is notifying doctors of the agency’s recommendation to increase monitoring of patients’ hearts after the first dose.

“The role of Gilenya in the reported cardiovascular events has not been fully established and the cause of this patient’s death is still unexplained,” Novartis said in an e-mailed statement, referring to the first reported death. It didn’t mention the other deaths reported by the EMA. “Novartis continues to believe that Gilenya provides an important health benefit.”

Julie Masow, a spokeswoman for Novartis, said in an e-mail the death rate is in line with the broader expected death rates based on the 30,000 multiple sclerosis patients who have been treated with Gilenya to date. She also said no significant differences in death rates were detected during clinical trials between patients on the medicine and controls.

First Oral Treatment

Gilenya was approved in the U.S. in 2010 as the first oral treatment for multiple sclerosis, and cleared for sale in Europe in March. With sales of $291 million for the first nine months of 2011, it’s among the products Novartis is depending on as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan.

Biogen Idec Inc. (BIIB) plans to submit its oral MS drug, called BG-12, to regulators during the first half of this year after it was safe and effective in a late-stage trial, the Weston, Massachusetts-based company said in October.

“Increased alertness to toxicities is not what Novartis needs,” said Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, in an e-mail. “Will the tox profile become Gilenya’s Achilles’ heel?”

The risk of slow heart rate, or bradycardia, after the first dose was known when the drug was approved, EMA said. The agency’s committee on human medicines expects to complete its review in March, the regulator said.

Patient Monitoring

Doctors should increase patient monitoring after the first dose is given, the EMA said. That includes electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour, the EMA said. After six hours, patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved.

More than 30,000 patients worldwide have now taken the medicine, according to the EMA statement.

Separately, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Novartis’s Signifor, the first treatment for Cushing’s disease in patients who can’t have surgery or for whom surgery hasn’t worked.

Cushing’s is a rare and deadly condition in which a small tumor produces too much of a certain hormone, resulting in weight gain in the face and neck, easy bruising and excessive growth of facial hair. It affects about 4 people in every 100,000 in the European Union, or about 20,000, the EMA said.

The European Commission usually follows the committee’s recommendations and delivers a final decision within three months, Novartis said in a statement.

The committee also recommended that Novartis’s cancer drug Gleevec be approved to treat patients with gastrointestinal stromal tumors for as much as three years, compared with one year now.

To contact the reporter on this story: Simeon Bennett in Geneva at

To contact the editor responsible for this story: Phil Serafino at

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