EMA warns of PML, cancer risks from Novartis' Gilenya

Earlier this year, U.S. regulators updated the label of Novartis' ($NVS) multiple sclerosis pill, Gilenya, to reflect cases of serious brain infections linked to the treatment. And now, its counterparts across the pond are following suit.

Friday, the Europeans Medicines Agency (EMA) announced it would add information about the infection--progressive multifocal leukoencephalopathy, or PML--to the med's product information, along with information about basal cell carcinoma and other risks associated with drugs that reduce the immune system's activity the way Gilenya does.

So far, three cases of PML have cropped up in Gilenya patients who had not received previous treatment with Biogen's ($BIIB) Tysabri--another immunosuppressive MS therapy--and 151 cases of basal cell carcinoma have been reported, regulators said.

The agency also issued new recommendations for doctors and patients concerning Gilenya's potential risks. Patients should be evaluated before and during Gilenya treatment in order to flag early signs of either malady, and they should receive a baseline MRI scan and a medical skin evaluation before starting treatment, the EMA said.

The new safety warnings could put a damper on things for Novartis, which counts Gilenya among its growth products. Last quarter, strong volume growth drove a 16% leap in constant currencies to $696 million in sales, the Swiss drugmaker said.

Gilenya isn't the only MS pill facing the PML problem, though. In July, Biogen confirmed a second case among patients taking its rival oral therapy Tecfidera, and the following month a report in The New England Journal of Medicine cautioned doctors that they could expect to see more of them surface in patients on the Massachusetts biotech's drug.

But on the Gilenya front, Novartis has other things to worry about, too. This fall, the U.S. Patent Trial and Appeal Board upturned a long-term patent on the med, putting it in line for early generic competition.

"Without novel IP, Gilenya will go generic in 2019 with multiple entrants," Bernstein analyst Ronny Gal predicted at the time.

- read the EMA release

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