The multiple sclerosis medication daclizumab (Zinbryta, Biogen/AbbVie) is being withdrawn from the market voluntarily following reports that it has been associated with inflammatory encephalitis and meningoencephalitis. The two companies said that “characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated.”
Pulling the drug “is in the best interest of patients,” said Alfred Sandrock, MD, PhD, Executive Vice President and Chief Medical Officer at Biogen.
Daclizumab, which is available in the European Union, U.S., Switzerland, Canada, and Australia, is used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, it is generally used in people who have tried two or more MS medicines that have not worked well enough.
News of the move came as the European Medicines Agency said that it was “urgently reviewing” daclizumab following cases of inflammatory brain disorders. Seven cases of encephalitis and meningoencephalitis turned up in Germany, with one occurring in Spain, FiercePharma reported.
Prior to the announcement, regulators had already taken actions around daclizumab’s liver safety. In the U.S., the product carried a boxed warning—the agency’s most serious—against use in patients with liver problems, along with a risk-management program.
Meanwhile, competition has been heating up in the MS market. Last year saw the entry of Roche’s Ocrevus, an eagerly awaited contender that FiercePharma said has “blockbuster” written all over it. Last summer, Bernstein analyst Ronny Gal wrote that daclizumab, beset by regulatory issues, “looks increasingly weak.”