(Reuters) – Biogen Inc said on Friday it will withdraw the marketing application for its controversial Alzheimer’s drug, aducanumab, in Europe after the U.S. biotech company failed to convince the European regulator of the treatment’s benefits.
The drugmaker said the move follows interactions with the European Medicines Agency that suggested data provided so far would not be enough to support an approval.
The agency in December rejected the drug, and Biogen had sought a re-examination of its decision.
“We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,” said Priya Singhal, Biogen’s interim head of research.
The drug was approved in the United States last June, a controversial decision since only one of two late-stage trials showed that it helped slow cognitive decline. The Food and Drug Administration’s own panel of outside experts had advised against approval.
The FDA decision was based on the drug’s ability to clear amyloid plaque from the brain, which the agency said is likely to slow cognitive decline for early Alzheimer’s patients.
The U.S. Centers for Medicare and Medicaid Services also did not agree with the decision. Medicare earlier this month severely limited its coverage of the drug to patients in clinical trials, which will significantly restrict patient access.
Analysts expect minimal sales of Aduhelm in the next few years.
“We see limited options for aducanumab and a commercial path forward,” BMO Capital Markets analyst Evan Seigerman said in a research note on Friday.
Eli Lilly and Co, Roche Holding AG and Eisai Co Ltd, which is partnered with Biogen, also have plaque-clearing drugs in late-stage development.
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