Novartis Dodges a Bullet from EMA

Novartis Dodges a Bullet from EMA

April 23rd, 2012 // 1:44 pm @

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After months of uncertainty, the European Medicines Agency has recommended continued use of the Gilenya multiple sclerosis pill sold by Novartis, although the regulator did say the drug should carry stronger warnings about heart risks. Although the risks were known at the time of approval two years ago, the review was made in response to patient deaths, including an unexplained sudden death of one person within 24 hours after taking Gilenya for the first time (back story).

The decision may lift a cloud that has been hovering over a key medication for Novartis, which has been counting on Gilenya to generate outsized sales and help compensate for the loss of patent protection on such big-selling drugs as the Diovan blood pressure pill. In a statement, David Epstein, who heads Novartis Pharmaceuticals, expressed relief and reiterated a “continued belief of the blockbuster potential of Gilenya.” In a conference call, Novartis execs say between 4 percent and 7 percent of MS patients may be at risk.

The EMA advised doctors not to prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering meds. If Gilenya is considered needed, heart rates should be monitored at least overnight following the first dose. But all patients should have an electrocardiogram and blood pressure measured before a first dose and for six hours after treatment. And continuous ECG monitoring is recommended (read the statement).

Despite these warnings, the EMA did not suggest that all Gilenya patients should be monitored overnight, which would have likely inhibited more widespread usage. The “worst case scenario of recommending the monitoring all patients overnight did not play out,” Robyn Karnauskas, a biotech analyst at Deutsche Bank, wrote in an investor note. She pointed out the EMA recommendations are “an extension of guidelines provided during investigation period.”

To what extent the FDA will take similar steps remains to be seen. Earlier this month, the Institute for Safe Medicine Practices called on the agency to substantially restrict Gilenya usage and enhance patient monitoring after reviewing adverse events that were reported to the FDA during the second quarter of 2011, shortly after the drug was approved. The watchdog group also criticized the agency for placing Gilenya in its fast-track approval process (read here).

“In the United States, the drug is approved for first-line use without restriction. In Europe, the drug is limited to second-line use in patients who have not responded to beta interferons, and whose disease is severe and rapidly progressing… I am among those who believe that the drug’s safety profile renders it unsuitable for unrestricted, first line use, and that the FDA needs to put additional safety measures in place,” ISMP senior scientist Thomas Moore writes us. He adds that other safety issues include pulmonary toxicity, adverse effects on the retina, safety in pregnant women, the risk of opportunistic infections, and a possible cancer risk.

Meanwhile, other challenges remain. Although Gilenya is the first MS pill, Biogen Idec plans to seek FDA approval to market its own pill shortly. And last week, Novartis reported that a patient taking its pill was diagnosed with progressive multifocal leukoencephalopathy, or PML, a rare and often fatal brain disease. However, the drugmaker believes the patient had been previously treated with another MS drug, Tysabri, which has been already associated with PML.


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