FDA approves Otsuka and Lundbeck’s schizophrenia treatment

(Reuters) – The U.S. Food and Drug Administration approved Danish drugmaker H. Lundbeck A/S and Japan’s Otsuka Pharmaceutical Co Ltd’s Rexulti, an anti-psychotic drug used to treat schizophrenia. The drug, brexpiprazole, was also approved as an adjunctive therapy for major depressive disorder (MDD), a serious psychiatric condition that can lead to persistent feelings of sadness, frustration or anger, the health regulator said on Friday. Otsuka Pharmaceutical is a unit of Otsuka Holdings Co Ltd. The agency based its decision on seven clinical trials, three of which examined the drug’s effect on schizophrenia and four testing it as an adjunctive therapy for MDD.

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FDA approves Otsuka and Lundbeck’s schizophrenia treatment