New death reports prompt EMA review of Gilenya

European regulators are taking a closer look at Novartis' ($NVS) multiple sclerosis pill Gilenya. After the November death of a 59-year-old patient who'd just begun Gilenya therapy, triggering an FDA safety review, the European Medicines Agency has received more reports of unexplained deaths of patients taking the med. While the EMA looks into the reports, it's advising doctors to monitor patients new to the drug more closely.

Novartis has pledged to hand over the results of its own probe into Gilenya's cardiovascular effects, the EMA said; the Swiss company said last month it was looking into the death of that 59-year-old U.S. patient. It's presumably planning to check out the other death reports cited by the EMA: Six Gilenya patients died of unknown causes, three of them suddenly, the health regulator said. Another four died from cardiovascular problems that may or may not have been caused by the drug, the agency noted.

Regulators have known that Gilenya can slow patients' heart rates after the first dose. FDA labeling requires new patients to be monitored for 6 hours after that first dose. Now, the EMA is advising doctors to do the same, as well as to check patients' vital signs every hour during that time. Patients with a slow heart rate or electrical issues in the heart should be monitored until those symptoms improve, the agency said.

Novartis wouldn't comment on the review, but at least one analyst isn't overly worried. "In my view this is highly unlikely to be related to the drug, but of course they have to check that," Helvea analyst Karl Heinz Koch told Bloomberg. "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."

Indeed, Novartis shares were off 2.1% this morning on the news. And not all Gilenya-watchers were so unconcerned. "Increased alertness to toxicities is not what Novartis needs," Vontobel's Andrew Weiss told the news service. "Will the tox profile become Gilenya's Achilles heel?"

- see the EMA release
- get more from Bloomberg

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