Biogen, AbbVie yank underperforming MS drug Zinbryta after encephalitis reports
It was a short run, but Biogen and AbbVie’s multiple sclerosis-fighter Zinbryta is coming off markets around the globe.
The pair revealed the decision on Friday, citing safety concerns and adding that “it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations” for the drug, which won FDA approval in May 2016.
News of the move came the same day as news from the European Medicines Agency that it was “urgently reviewing” Zinbryta following cases of inflammatory brain disorders. Seven cases of encephalitis and meningoencephalitis turned up in Germany, with one occurring in Spain.
Now, the companies will “work collaboratively” with regulators and healthcare providers all over the world as they withdraw the drug. Current Zinbryta patients should speak with their doctors about any questions or concerns, the companies advised.
Prior to Friday, regulators had already taken actions around Zinbryta’s liver safety. In the U.S., the product carried a black-box warning—the agency’s most serious—against use in patients with liver problems, along with a risk-management program. And in Europe, regulators put limits on its use and required strict liver monitoring.
With things heating up in the multiple sclerosis space, it wasn’t a good time for a product to be gaining restrictions. Last year saw the entry of Roche’s Ocrevus, an eagerly awaited contender with “blockbuster” written all over it.
“This drug looks increasingly weak,” Bernstein analyst Ronny Gal wrote last summer, citing Zinbryta’s European regulatory woes.
Meanwhile, MS-focused Biogen may be looking to further diversify through a little dealmaking action. Rumor has it that the big biotech has its eye on Acorda and its forthcoming Parkinson’s medicine, Inbrija.