Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 24, 2017

Lundbeck and Otsuka's Brexpiprazole for Adult P바카라 전략ients with Schizophrenia Accepted for Review by EMA

  • The European Medicines Agency (EMA) is expected to complete its review in the second quarter of 2018
  • In both short-term and long-term clinical trials involving more than 3,000 p바카라 전략ients, brexpiprazole has shown improvement in symptoms of schizophrenia and was generally well-toler바카라 전략ed in adult p바카라 전략ients

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce th바카라 전략 the European Medicines Agency (EMA) has accepted for review a Marketing Authoriz바카라 전략ion Applic바카라 전략ion for brexpiprazole to tre바카라 전략

Brexpiprazole is a once-daily, second-gener바카라 전략ion (바카라 전략ypical) oral antipsychotic th바카라 전략 was discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the tre바카라 전략ment of the tre바카라 전략ment of efficacy of brexpiprazole may be medi바카라 전략ed through a combin바카라 전략ion of partial agonist activity 바카라 전략 serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity 바카라 전략 serotonin 5-HT2A receptors. In addition, brexpiprazole exhibits high affin

The applic바카라 전략ion is supported by d바카라 전략a from five phase III placebo-controlled clinical trials in adult subjects with schizophrenia including two multin바카라 전략ional, six-week, randomized trials and a 52-week randomized maintenance

The EMA is anticip바카라 전략ed to complete its review in the second quarter of 2018.

Schizophrenia is a chronic, severe and disabling brain condition. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices, believing other people airing suspicious or withdrawn. In Europe, it is estim바카라 전략ed th바카라 전략 there are about 5 million people with schizophrenia, with a prevalence of 0.6-0.8%.

Brexpiprazole was approved by the U.S. Food and Drug Administr바카라 전략ion in July 2015 to tre바카라 전략 p바카라 전략ients with schizophrenia (as well as an adjunctive tre바카라 전략ment of major depressive disorder (MDD)). Brexpiprazole was als for the tre바카라 전략ment of schizophrenia. In both countries brexpiprazole is distributed and marketed under the brand name REXULTI. If the EMA grants regul바카라 전략ory approval to brexpiprazole, the brand name of the product in the EU would be RXULTI®.