The marketing effort for the MS drug Zinbryta (daclizumab) imploded today after European regulators flagged a lethal safety warning over cases of inflammatory encephalitis and meningoencephalitis. Biogen $BIIB and AbbVie $ABBV, which had been looking to spend this year building sales of the MS treatment, are now yanking it off the market in the EU and the US.
“Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated,” the companies said in a statement. “Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”
Encephalitis is characterized by brain inflammation, usually caused by a viral infection, which is rare and potentially deadly.
The drug hit the US market in 2016 with a black box warning over the threat of liver toxicity after the FDA approved it for third-line MS cases. Regulators, though, have been willing to put up with considerable safety problems with MS drugs so long as the damage to patients is rare and the benefits considerable. In this case, Biogen and AbbVie have yet to gain much traction for a drug that analysts had felt would be limited to peak sales of $500 million a year.
The withdrawal won’t have much impact on AbbVie longterm, where the R&D group is in hot pursuit of several potential blockbusters to bolster its work around Humira. Biogen, though, won’t get off so easy. The big biotech made its rep in MS and has a thin pipeline dominated by a high-risk Alzheimer’s therapy. Biogen CMO Al Sandrock managed to rattle the market recently with news that they were adding patients to their pivotal trial for the Alzheimer’s drug to account for some variability in the data — which in turn triggered fresh jitters over its future.
“Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” said Sandrock in a statement. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
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