US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug

BioArctic AB

26/01/2025 23:30

Jan 27 (Reuters) - The U.S. Food and Drug Administration
has approved monthly maintenance dosing for Japan's Eisai
 4523.T  and partner Biogen's  BIIB.O  Alzheimer's drug Leqembi,
the companies said on Monday.
        The drug received 
    standard U.S. approval
     in 2023 after showing it slowed cognitive decline in
patients with the brain-wasting disease but growth has been
slow, in part because its administration is time-consuming and
it requires regular MRIs and screenings.
  
    Patients can switch to a monthly dose after having received
an intravenous infusion of the drug every two weeks for 18
months, the companies said in a joint statement. They can also
continue to dose once every two weeks.
        Leqembi clears sticky deposits of a protein called
amyloid beta in the brain, believed to be a hallmark of
Alzheimer's disease. Patients receive the drug at an infusion
center in almost an hour-long process.
    The companies said that modeling simulations of trial data
predicted that maintenance dosing would maintain benefits of the
therapy.
        A rival drug from Eli Lilly  LLY.N , Kisunla, was
approved in July and is given by infusion once a month. Patients
stop taking the treatment once brain scans no longer show
amyloid plaques.
    Both drugs have safety warnings regarding the potential for
brain swelling and bleeds. Patients are recommended to undergo
monitoring with scans.
    Eisai has a collaboration agreement with BioArctic
 BIOAb.ST  on the drug.

 (Reporting by Mariam Sunny, Bhanvi Satija and Surbhi Misra in
Bengaluru; Editing by Caroline Humer and Richard Chang)
 ((Surbhi.Misra@thomsonreuters.com |  X: https://twitter.com/SurbhiMisra_
  |))