FDA accepts one, delays another; Data, deals and dollars for slate of biotechs
The schizophrenia and major depressive disorder drug out of Otsuka Pharmaceutical and Lundbeck is now under priority review at the FDA for another indication.
The drug developers said the regulator will decide whether to expand the label of brexpiprazole, marketed as Rexulti for approved indications, to include agitation associated with Alzheimer’s dementia by May 10. The companies said the FDA indicated it plans to convene an expert panel to advise on the application.
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