Veterans to receive coverage of treatment for early-stage AD

Key takeaways:

• The Veterans’ Health Administration will cover Alzheimer’s drug Leqembi for eligible veterans.
• Leqembi maker Eisai awaits FDA approval by the traditional pathway.

The Veterans’ Health Administration will provide coverage of a drug for the treatment of Alzheimer’s disease to veterans with early stages of the disease, according to a press release from the drug’s manufacturer.

The drug, lecanemab-irmb (Leqembi, Eisai Co.) is a humanized immunoglobulin gamma 1 monoclonal antibody that was granted accelerated approval by the FDA on Jan. 6. Leqembi’s approval was based on findings from a phase 2 trial that showed a reduction in the accumulation of amyloid beta, Eisai said in the press release.

Based on confirmatory phase 3 data, Eisai submitted a supplemental Biologics License Application (sBLA) to secure FDA approval via the traditional pathway. The FDA granted the sBLA priority review with a prescription drug user fee act date of July 6, according to the release. If approved, the FDA will update Leqembi’s label to reflect the findings from the phase 3 study.