EMA Panel Recommends Brexipiprazole for Schizophrenia

Caroline Cassels


June 01, 2018

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorization for brexipiprazole (Rxulti, Otsuka Pharmaceutical Europe Ltd) for the treatment of schizophrenia.

Brexipiprazole is antipsychotic that binds primarily to dopamine D2 receptors, serotonin 5-HT1A and 5-HT2A receptors, and noradrenergic α1B/2C receptors (ATC code: N05AX16).

In 2015, the drug was approved in the United States for the treatment of schizophrenia and as an adjunctive therapy for major depression.

More recent research suggests it may also be effective in reducing agitation associated with Alzheimer's disease.

Brexipiprazole will be available as film-coated tablets (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg).

The CHMP notes that the benefits of the drug are its ability to improve psychotic symptoms. The most common side effects are akathisia and weight gain.

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