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

Anticoagulant Use In Spotlight As Approval Nears

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...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By 

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D