FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy (updated)

Brainstorm Cell Therapeutics

25/09/2023 13:31

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       Sept 25 (Reuters) - The U.S. Food and Drug
Administration's staff reviewers raised concerns on Monday over
the safety and efficacy of BrainStorm Cell Therapeutics'
 BCLI.O  amyotrophic lateral sclerosis (ALS) therapy, sending
the company's shares down 50% in premarket trading.
    Brainstrom's therapy NurOwn is being reviewed for the
treatment of ALS, also known as Lou Gehrig's Disease, a
progressive neurodegenerative disease that affects nerve cells
in the brain and spinal cord.
    The FDA, in its briefing documents, said it does not believe
there is sufficient evidence to support NurOwn's clinical
benefit, adding there were large amounts of missing data.
    The health regulator also identified a higher incidence of
deaths in the treatment group and said it indicates a lack of
survival benefit and warrants further investigation.
    A panel of external advisors to the FDA is set to vote on
the effectiveness of the therapy in ALS patients on Wednesday.  
     

 (Reporting by Mariam Sunny in Bengaluru; Editing by Krishna
Chandra Eluri)
 ((Mariam.ESunny@thomsonreuters.com;))