
Jul 18 2025
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FDA approves treatment for schizophrenia in pediatric patients
Otsuka and Lundbeck’s supplemental new drug application (sNDA) for brexpiprazole to treat schizophrenia in pediatric patients aged 13 to 17 years has been approved by the US Food and Drug Administration (FDA). The FDA had previously granted priority review for the sNDA. Brexpiprazole was approved in the United States in 2015 to treat schizophrenia in adults and the adjunctive treatment of major depressive disorder.
Source: Otsuka Holdings Co. Ltd.
Schizophrenia is a chronic, severe, and disabling brain disease. The symptoms of Schizophrenia may leave afflicted persons fearful and withdrawn. Their speech and behavior can become so disorganized that they are incomprehensible or frightening to others. Available treatments can relieve many schizophrenic symptoms, but most people with schizophrenia continue to suffer some signs throughout their lives; it has been estimated that no more than one in five individuals recovers completely. Schizophrenic disorders have a multifactorial etiology, with genetic, environmental, and neurotransmitter pathophysiological components. At present, no laboratory method confirms a diagnosis of Schizophrenia. There may or may not be a history of a significant disruption in the person’s life (failure, loss, physical illness) before gross psychotic deterioration is evident.
- The annual incidence of Schizophrenia varies between 11 to 25 cases per every 100,000 populations in the USA.
However, the current Schizophrenia treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (Brexpiprazole, Cariprazine, CTP-692, Luvadaxistat, MK-8189, etc.) have been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.
In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Schizophrenia treatment. The key companies in the advanced development stage are Otsuka Pharmaceutical, Forest Laboratories, Concert Pharmaceuticals, Neurocrine Biosciences, etc.
Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market insight report on Schizophrenia to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.
Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.
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