EMA review confirms that risks of Biogen, AbbVie's MS drug Zinbryta outweigh benefits

The European Medicines Agency said Friday that its review of Biogen and AbbVie's Zinbryta (daclizumab) has confirmed that the multiple sclerosis (MS) drug "poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs." The European Commission withdrew Zinbryta's marketing authorisation in late March at Biogen's request after the drug had been linked with 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis, with three fatal cases.

According to the EMA, "patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected." The agency noted that its findings "[confirm] its previous conclusions that risks of Zinbryta outweigh its benefits for patients with MS."

FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

The once-monthly, self-administered, subcutaneous injection was initially cleared in Europe in 2016 for the treatment of adults with relapsing forms of MS. Last year, the EMA provisionally restricted use of the drug after launching a safety review related to the treatment's potential liver risks. The agency later imposed more restrictions on the therapy after the review had uncovered evidence of "unpredictable and potentially fatal immune-mediated liver injury [that] can occur during treatment with Zinbryta and for up to six months after stopping treatment."

Biogen and AbbVie voluntarily pulled Zinbryta from all markets in early March, including in the EU, US and Canada.

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