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

Reuters · 05/11/2023 03:36
Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug

- 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))