EMA suspends, recalls AbbVie and Biogen's doomed MS drug Zinbryta

Europe
European regulators announced on Friday that they were "urgently reviewing" Zinbryta on safety concerns. (CC0 Public Domain)

Less than a week after announcing that they were “urgently reviewing” AbbVie and Biogen multiple sclerosis drug Zinbryta on safety concerns, European regulators are recommending an immediate suspension and recall of the product.

The European Medicines Agency announced the move on Wednesday, citing 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of those cases led to patient deaths, the agency noted.

And that’s not all. “Zinbryta may also be linked to severe immune reactions affecting several other organs,” the body warned.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

The suspension and recall follow AbbVie and Biogen’s decision to yank the drug from markets around the globe. The pair made the call on Friday, the same day the EMA unveiled its review.

RELATED: Biogen, AbbVie yank underperforming MS drug Zinbryta after encephalitis reports

Friday wasn’t the first time Zinbryta had stirred up safety concerns, though. In the U.S., the drug carried a black-box warning against use in patients with liver problems, and in Europe, regulators had placed limits on its use and required strict liver monitoring.

RELATED: Biogen, AbbVie hit with Zinbryta safety action in EU as MS market heats up

For now, the EMA advised, doctors should contact their Zinbryta patients immediately to stop their treatment and look for an alternative therapy. Once stopping therapy, patients should be followed up with for at least 6 months, it said.