Lecanemab

A groundbreaking Alzheimer's drug, Leqembi, has been approved for use in the EU, targeting amyloid plaques. Initially blocked in July, the European Medicines Agency (EMA) approved it in August, recommending it for patients not in advanced stages. Developed by Eisai and Biogen, it's also approved in the US, Japan, and China. The drug is available in the UK under a different name, with potential side effects including ARIA. The EMA's approval is restricted to patients with lower risk of brain hemorrhage and fewer copies of the ApoE4 gene.

EMA approves Leqembi, first treatment for slowing Alzheimer's cognitive decline, reversing earlier rejection due to side effect concerns. Targeting early signs, it shows reduced cognitive decline in trials, but is limited to mild cases and those without ApoE4 gene risk. Developed by Eisai and Biogen, it has been approved globally, offering hope but not a cure, with potential to transform neurodegenerative disease treatment landscapes.

EMA’s CHMP reconsiders Leqembi approval, now positive if high-risk APOE4 patients are excluded. Initially opposed due to safety concerns, CHMP now backs approval for patients with zero or one APOE4 allele.

The EU approves Leqembi, a life-changing Alzheimer's drug, for patients not in advanced stages, after initial rejection due to risks like brain bleeding. The treatment, developed by Eisai and Biogen, is also approved in the UK, US, Japan, and China. It targets amyloid plaques and is available under different names in various countries, with a controlled release to manage risks.

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Michael Yee of Jefferies maintains a Buy rating on Biogen (BIIB) with a $250.00 price target, citing positive developments for Biogen’s Alzheimer’s drug, Leqembi, in the European market. The European Medicines Agency’s approval recommendation, despite limitations, is seen as a significant market opportunity. Challenges include EU pricing and reimbursement processes, logistical issues, and the need for pipeline expansion, but the drug’s potential in specific patient groups supports the Buy recommendation.

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The EMA partially approved Leqembi for mild cognitive impairment or mild dementia due to Alzheimer’s, limited to patients with one or no ApoE4 gene copy, to minimize brain bleeding risks. Leqembi, developed by Biogen and Eisai, targets early Alzheimer’s stages by clearing harmful proteins and has shown to reduce cognitive decline by 25%.

EMA's CHMP recommended 8 new medicines for approval, including Augtyro, Gohibic, and Lazcluze, and 4 biosimilars. Extensions of indication were recommended for 11 existing medicines, while marketing authorisations were refused for Cinainu and Kizfizo. CHMP also recommended Leqembi for Alzheimer's patients with specific genetic profiles and updated safety advice for Mysimba. Applications for Izelvay and Inaqovi were withdrawn.

EMA recommends EU approval of Leqembi, the first Alzheimer’s treatment that slows disease progression, for patients with one or no ApoE4 gene copy. The treatment, made by Eisai and Biogen, was previously rejected due to high side effect risks.