Eisai and Biogen Receive the US FDA’s Approval of Leqembi (lecanemab-irmb) for Alzheimer's Disease
- The US FDA has approved Leqembi (100mg/mL, IV, q2w) for AD under the accelerated approval pathway. The product is expected to be available during or before Jan 23, 2023
- The approval was based on the P-II study of Leqembi (humanized IgG1 mAb) which showed a reduction in the accumulation of Aβ plaque in the brain. The company also submitted sBLA to the US FDA for approval under the traditional pathway, based on the P-III trial (Clarity AD) presented at CTAD conference & published in the NEJM
- The company launched the patient support program, providing access to patients for Leqembi treatment incl. insurance coverage & co-pay programs. At the same time, PAP offers Leqembi at no cost for eligible uninsured & underinsured patients, incl. Medicare beneficiaries
Ref: Biogen | Image: Eisai
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