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Eisai and Biogen Receive the US FDA’s Approval of Leqembi (lecanemab-irmb) for Alzheimer's Disease

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Eisai and Biogen Receive the US FDA’s Approval of Leqembi (lecanemab-irmb) for Alzheimer's Disease

Shots:

  • 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

Related News:- Eisai and Biogen Publishes Results of P-III Study (Clarity AD) of Lecanemab for Early Alzheimer's Disease

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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