- Eisai Co Ltd ESALY and Biogen Inc BIIB said the U.S. Department of Veteran Affairs (VA) would provide coverage of their Alzheimer's treatment Leqembi (lecanemab) to veterans at an early stage.
- A document shows that the FDA added Leqembi, making it available provided patients request it, receive prior approval, and meet strict inclusion criteria for the drug's use.
- The companies set an initial annual price of about $26,500 for Leqembi.
- Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid beta (Aβ).
- The FDA approved the treatment under the Accelerated Approval Pathway for Alzheimer's Disease (AD).
- The FDA has accepted a supplemental application supporting the conversion of the accelerated approval of Leqembi to a traditional approval.
- The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.
- William Blair says the VA decision begins a potential series of wins on the reimbursement front for Leqembi. The larger catalyst is the CMS potentially revisiting the currently restrictive NCD after full approval.
- Not all veterans living with AD will be eligible for treatment, but unlocking reimbursement for these beneficiaries puts Eisai on course to identify 100,000 patients eligible for treatment by 2026.
- The analyst sees the coverage decision as an incremental positive for the commercial potential of Leqembi and unlocking a $2.5 billion-plus current market opportunity.
- Price Action: BIIB shares are up 0.78% at $260.57 on the last check Tuesday.
- Photo Via Company
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
