Bloomberg News

Novartis’s Gilenya MS Pill Gets New Safety Rules

April 20, 2012

U.S. and European regulators placed new safety precautions on the use of Novartis AG’s (NOVN) multiple- sclerosis pill Gilenya following a three-month review triggered by the deaths of 15 patients.

Doctors shouldn’t prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication, the European Medicines Agency said today in a statement. The U.S. Food and Drug Administration set a similar rule, Novartis said in a separate statement. When treatment with Gilenya is necessary in these patients, their heart activity should be monitored at least overnight after the first dose, the London-based EMA said.

“It’s certainly not any restriction of the label,” Nicholas Turner, a London-based analyst for Mirabaud Securities, said in a telephone interview today of the EU changes. “My reading of it is that the EMA are endorsing the safety of Gilenya. It’s not bad news for the medicine. If anything it’s the opposite.” The same is true of the FDA changes, he said.

The pill is among the products Novartis is depending on as patents start to expire on the company’s best-selling medicines, including the hypertension drug Diovan. More than 36,000 patients worldwide have now taken Gilenya, according to Novartis. For its review, the EU agency examined heart-safety data on the medicine as well as reports of sudden or unexplained deaths.

Treatment Option

Novartis shares rose 0.5 percent to close at 51.20 Swiss francs in Zurich.

“We believe that Gilenya is a valuable treatment option for many patients with relapsing remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug, which also supports our continued belief of the blockbuster potential of Gilenya,” David Epstein, head of the Basel, Switzerland-based company’s pharmaceutical division, said in a statement about the EMA’s review.

The EU regulator also recommended that all patients starting treatment with Gilenya should have their heart activity monitored before receiving the first dose of the medicine and continuously for at least six hours after. The FDA requires an electrocardiogram before the first dose, and after the six-hour first-dose observation period, the company said.

U.S. Death

Monitoring should be extended for at least two hours in patients whose heart rate is lowest six hours after receiving the first dose of Gilenya, the agency said. In patients who develop significant heart problems such as a slow heart rate or a problem with the conduction of electricity in the heart, monitoring should continue at least overnight and until the issues have been resolved.

Novartis said Dec. 12 that a U.S. patient died within 24 hours of starting treatment with Gilenya, triggering reviews by the FDA and the 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 regulator said Jan. 20.

The EMA said today it looked at 15 cases of sudden or unexplained deaths. “Most of the deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or taking other medicines,” the regulator said. “However, the data reviewed were not conclusive as to whether Gilenya was the cause of the deaths.”

U.S. Approval

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 2011. It’s been known since the drug was approved that patients taking it may experience heart-rhythm disorders or a short-lived drop in their heart rates, and warnings about those risks were included on the label, the EMA said.

The drug earned Novartis $494 million last year and may reach sales of $2.27 billion in 2016, according to the average of seven analyst estimates compiled by Bloomberg.

To contact the reporters on this story: Kristen Hallam in London at khallam@bloomberg.net; Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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