FDA Grants Leqembi Priority Review for Full Approval

The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA) to traditional approval.

The agency granted the antiamyloid antibody AA on Jan. 6 and Leqembi launched commercially on Jan. 18. The priority review designation following quickly after Accelerated Approval signals the FDA’s continuing commitment to getting a much-needed treatment to the public quickly. The review timeline is now four months shorter with a target decision date of July 6.

Leqembi is a humanized immunoglobulin gamma 1 monoclonal antibody directed against amyloid beta in patients with a mild cognitive impairment or mild dementia stage of the disease and confirmed presence of amyloid beta.

Topline numbers showed that Leqembi slowed cognitive decline in treated patients by 27 percent.