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Is Lecanemab Plus t-PA A Deadly Combination? One Case Study May Shed Light

Anticoagulant Use In Spotlight As Approval Nears

 
• By Mandy Jackson

A letter in the New England Journal of Medicine suggests the death of one extension trial participant treated with t-PA may have been caused by lecanemab, but a response notes fatal intracerebral hemorrhages have been seen after t-PA in certain patients in the absence of anti-amyloid drugs.

CT scan of brain with red area ( Imaging for hemorrhagic stroke or Ischemic stroke ( infarction ) concept )
Lethal brain hemorrhage has been observed in three lecanemab trial participants, including one who received placebo • Source: Shutterstock

Eisai Co., Ltd. and Biogen, Inc. should hear from the US Food and Drug Administration any day now whether the agency will grant accelerated approval for the amyloid protofibril-targeting antibody lecanemab, but one issue looming large over the treatment for early Alzheimer’s disease is how safe it will be for frail, elderly patients – particularly for individuals taking anticoagulants for cardiovascular disease or treated in the emergency room for a stroke. A new case study looking at one lecanemab clinical trial participant who died following anticoagulant use attempts to shed some light on the safety concern.

The New England Journal of Medicine (NEJM) published the case study on 4 January in a letter written by Nicholas Reish and 11 other doctors from Northwestern University Feinberg School of Medicine in Chicago, along with a response letter from two investigators involved in Eisai/Biogen’s pivotal Phase III Clarity AD clinical trial, Marwan Sabbagh of

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.