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Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk

 
• By Sue Sutter

Labeling for the first anti-amyloid to receive traditional approval in Alzheimer’s disease states that testing for ApoE ε4 status ‘should be performed’ prior to treatment; updated labeling also includes stronger cautionary language on use in patients with risk factors for cerebral hemorrhage.

Black box
Leqembi's regular approval came with a proverbial "black box" warning on ARIA risks. • Source: Shutterstock

The US Food and Drug Administration’s conversion from accelerated to regular approval of Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi (lecanemab-irmb) comes with amped up safety information in the product label, including a new boxed warning on amyloid-related imaging abnormalities and stronger recommendations for pretreatment genetic testing.

On 6 July, the FDA granted full approval to lecanemab, making it the first amyloid beta-directed antibody – and the first disease-modifying drug – to receive

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• By Sarah Karlin-Smith

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New EU Filings

 
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Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

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• By Neena Brizmohun

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