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Latest From Eisai Co., Ltd.

Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Advisory Committees Drug Review

Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Advisory Committees Drug Review

Chinese Language Podcast: ASCO专集

J&J and Legend’s Carvykti shines at ASCO while Junshi provides PD-1 antibody toripalimab updates. Alongside, ADCs from Biokin, BlissBio also steps into the spotlight. Guest speaker Leon Tang in the US, Brian Yang in Beijing and Dexter Yan in Shanghai discuss what stands out in this special ASCO episode of the latest Chinese-language podcast. 

China Clinical Trials

Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members

Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.

Advisory Committees Review Pathway
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    • EA Pharma Co., Ltd.
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    • Eisai Participacoes Ltda. (Brazil Subsidiary)
    • H3 Biomedicine
    • HI-Eisai Pharmaceutical Inc.
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    • Liaoning TianYi Biological Pharmaceutical Co., Ltd.
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