Marking the second approval of an Alzheimer’s disease treatment aimed at slowing cognitive decline by reducing amyloid plaque buildup on the brain, the FDA on Jan. 6 granted accelerated approval to Biogen and Eisai, Co., Ltd.’s Leqembi (lecanemab-irmb). For now, the drug remains subject to the restrictive National Coverage Determination that Medicare initially gave its predecessor, Aduhelm (aducanumab-avwa), and similar Alzheimer’s treatments last year, but CMS could consider broader coverage if the drug receives traditional FDA approval.
The drug is indicated for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia. Patients must have confirmed presence of amyloid beta pathology before starting treatment. The FDA gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations. Japanese pharmaceutical company Eisai developed the drug and will co-market it with its U.S. partner Biogen, which launched Aduhelm in 2021 and had to halve its price from $56,000 a year to $28,000. Eisai estimates the cost of Leqembi will be $26,500 per year, though the actual price could vary by patient.