- Eisai Co Ltd ESALY And Biogen Inc BIIB said the U.S. Department of Veterans Affairs (VA) will provide early-stage information to veterans about their Alzheimer’s treatment Leqembi (lecanemab).
- A document shows that the FDA has added Leqembi and made it available subject to patients requesting it, obtaining prior approval, and meeting strict inclusion criteria for using the drug.
- The companies set an initial annual price for Leqembi of approximately US$26,500.
- Leqembi is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of beta-amyloid (Aβ).
- The The FDA approved the treatment under the Accelerated Approval Pathway for Alzheimer’s disease (AD).
- The FDA has accepted an amendment supporting the conversion of Leqembi’s accelerated approval to a traditional approval.
- The Leqembi motion was granted priority consideration with a Prescription Drug User Fee Act Action date July 6, 2023.
- William Blair says the VA decision starts a potential series of gains on the reimbursement front for Leqembi. The larger catalyst is the CMS, which, once fully approved, may revisit the currently restrictive NCD.
- Not all veterans living with AD are eligible for treatment, but unlocking reimbursement for these beneficiaries puts Eisai on track to identify 100,000 patients eligible for treatment by 2026.
- The analyst sees the coverage decision as an additional plus for Leqembi’s commercial potential and as unlocking a current market opportunity of over US$2.5 billion.
- Price promotion: BIIB shares are up 0.78% to $260.57 on the latest check Tuesday.
- Photo via company
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