Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug (updated)
11/05/2023 04:48
(Updates with background)
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 outweigh its risks.
Patients with Alzheimer's sometimes show signs of extreme
aggression or become restless and anxious as their brain loses
its ability to negotiate with new stimulus as a result of the
disease.
Presently in the U.S., such patients are calmed down using
non-pharmacological strategies first, only to be followed by
off-label treatment with antipsychotics and anti-depressants in
worse scenarios.
The approval of brexpiprazole is based on two late-stage
studies, which showed significant improvement in calming
agitated patients with Alzheimer's, when compared with a
placebo.
Brexpiprazole, co-developed with Danish drugmaker Lundbeck
HLUNb.CO , was previously approved in the U.S. to treat adults
with major depressive disorder and schizophrenia.
(Reporting by Aditya Samal and Shivani Tanna in Bengaluru;
Editing by Shounak Dasgupta and Sonia Cheema)
((Aditya.Samal@thomsonreuters.com))