Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug

H Lundbeck A/S

11/05/2023 04:36

May 11 (Reuters) - The U.S. Food and Drug Administration
approved Otsuka Pharmaceutical's  4578.T  brexpiprazole to treat
agitation in patients with Alzheimer's on Thursday, making it
the first approved drug for the indication, the company said in
a statement.
    The decision comes after an advisory panel in April voted
9-1 that the company had enough data to identify the population
in whom benefits from the treatment outweighs its risks.
    

 (Reporting by Aditya Samal; Editing by Shounak Dasgupta)
 ((Aditya.Samal@thomsonreuters.com))