Biogen and Abbvie Take Multiple Sclerosis Drug Off Market -- Update
By Peter Loftus
Drugmakers Biogen Inc. and AbbVie Inc. said Friday they are pulling their new multiple-sclerosis treatment Zinbryta from all global markets after several European patients suffered serious inflammatory brain disorders.
The European Medicines Agency, which regulates drugs in the European Union, said Friday it started an "urgent review" of the drug because eight MS patients experienced encephalitis and other brain inflammations after taking the injected drug. Seven were in Germany and one was in Spain.
The EMA said doctors shouldn't start any patients on Zinbryta, and should find alternatives for patients currently taking the drug. There are more than a dozen other MS drugs on the market that are considered "disease-modifying," meaning they can slow the natural progression of MS, including Biogen's Avonex, said Bruce Bebo, executive vice president of research programs at the National Multiple Sclerosis Society.
The companies said patients taking Zinbryta should contact their doctors with questions. The U.S. Food and Drug Administration will work with the companies to make sure there is an appropriate transition plan for patients taking the drug, an agency spokeswoman said.
More than 8,000 patients have been treated with Zinbryta world-wide since its introduction in 2016 as a treatment for adults with relapsing forms of MS, the EMA said. The MS society estimates about 2.5 million people world-wide have the disease, which causes neurological disabilities like vision loss, and is incurable.
"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. "Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw world-wide marketing authorizations for Zinbryta."
AbbVie and Biogen co-promote the drug in the U.S., Canada and Europe, sharing profits and losses. Last year, Biogen recorded $52.7 million in sales of Zinbryta outside the U.S., according to its annual report. AbbVie didn't disclose Zinbryta sales in its annual report.
The drug has been dogged by safety concerns. The U.S. Food and Drug Administration approved its use in 2016 with a strong warning that it can cause severe liver injury, immune conditions and other serious side effects. Because of the risks, the FDA said with its approval in 2016 the drug should only be used by patients who didn't respond well to at least two other MS drugs.
Last year, citing the liver side effects, the EMA restricted the drug's use to patients who tried at least two other MS drugs and couldn't be treated with any other MS drugs.
The EMA restrictions on Zinbryta's use led the companies to write down the asset value of the drug, based on reduced expectations of future cash flows, according to their annual reports.
Write to Peter Loftus at firstname.lastname@example.org
(END) Dow Jones Newswires
March 02, 2018 14:58 ET (19:58 GMT)Copyright (c) 2018 Dow Jones & Company, Inc.