Japan Drugmaker Seeks Fast U.S. Approval for Another Alzheimer’s Drug

(Bloomberg) -- Eisai Co. Ltd. said it is seeking a swift U.S. approval of an another Alzheimer’s disease therapy, just months after the controversial clearance of a similar treatment for the memory-destroying illness.

The Japanese drugmaker said that it and its U.S.-based partner Biogen Inc. have begun a rolling submission with the Food and Drug Administration for an accelerated approval of the drug lecanemab. Like the companies’ recently approved Aduhelm, lecanemab targets amyloid, a plaque that builds up in the brains of some people with Alzheimer’s disease. 

Some scientists think clearing amyloid could treat the debilitating condition, though what role it plays in the disease has been debated for years, and the question remains far from settled. The FDA granted Aduhelm an accelerated approval based on studies showing the drug reduced plaque rather than evidence that it slows cognitive decline. 

The agency’s decision came despite the objections of its own advisory panel, which voted unanimously against allowing the drug on the market without further study. Three of the panel members resigned in protest of the clearance, and other top researchers called it a “regulatory failure.” Congress is investigating what lawmakers have called anomalies in the approval.

Despite the blowback, the FDA’s accelerated approval of Aduhelm opened the door for companies to pursue rapid reviews of other amyloid-targeting treatments.

Eisai said in a statement it was submitting lecanemab for accelerated approval after talks with the FDA. In June, the agency designated the drug as a breakthrough therapy, a tag that is intended to speed up the bringing of drugs for life-threatening conditions to market.

In a study of 856 patients, lecanemab significantly reduced amyloid in the brain, Eisai said. The data were published in the journal Alzheimer’s Research & Therapy in April. A late-stage clinical trial of 1,795 patients is ongoing. 

Since its approval, Aduhelm sales have been slow, as some insurers have balked at paying for it and doctors at some prominent medical facilities have said they won’t administer it.

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