EC extends brexpiprazole indication to incorporate adolescents
Otsuka Pharmaceutical Europe and Lundbeck have introduced that the European Fee has permitted Rxulti (brexpiprazole) for the remedy of schizophrenia in adolescents aged 13 years and older.
The approval follows a constructive opinion from the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company in January 2025.
The choice was based mostly on a 6-week, randomised, double-blind placebo-controlled and active-referenced trial involving 316 adolescent sufferers. The research evaluated the efficacy and security profile of brexpiprazole, displaying higher reductions in symptom severity, as measured by the Optimistic and Destructive Syndrome Scale (PANSS) complete rating in contrast with placebo.
Brexpiprazole, dosed at 2-4 mg/day, was usually nicely tolerated with a security profile according to that noticed in grownup sufferers with schizophrenia.
Andy Hodge, CEO at Otsuka Pharmaceutical Europe, mentioned: “The prognosis for adolescence-onset schizophrenia is poor in contrast with adult-onset schizophrenia and might be related to extra persistent and extreme signs. We welcome the EC resolution to increase the indication for brexpiprazole to incorporate adolescents aged 13 years and older, offering younger folks in Europe with one other much-needed remedy possibility.”
Johan Luthman, EVP and Head of Analysis & Improvement at Lundbeck, mentioned: “As we speak marks a serious milestone for younger sufferers, caregivers, and households navigating the complexities of schizophrenia. This approval is testomony to our dedication and unwavering assist to reduce the illness burden for sufferers and caregivers within the EU by offering a remedy possibility with confirmed efficacy and tolerability.”
Brexpiprazole is an atypical oral antipsychotic taken as soon as a day, modulating serotonin and dopamine methods. It was beforehand permitted within the European Union in 2018 for the remedy of grownup schizophrenia.
EC extends brexpiprazole indication to incorporate adolescents
Otsuka Pharmaceutical Europe and Lundbeck have introduced that the European Fee has permitted Rxulti (brexpiprazole) for the remedy of schizophrenia in adolescents aged 13 years and older.
The approval follows a constructive opinion from the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company in January 2025.
The choice was based mostly on a 6-week, randomised, double-blind placebo-controlled and active-referenced trial involving 316 adolescent sufferers. The research evaluated the efficacy and security profile of brexpiprazole, displaying higher reductions in symptom severity, as measured by the Optimistic and Destructive Syndrome Scale (PANSS) complete rating in contrast with placebo.
Brexpiprazole, dosed at 2-4 mg/day, was usually nicely tolerated with a security profile according to that noticed in grownup sufferers with schizophrenia.
Andy Hodge, CEO at Otsuka Pharmaceutical Europe, mentioned: “The prognosis for adolescence-onset schizophrenia is poor in contrast with adult-onset schizophrenia and might be related to extra persistent and extreme signs. We welcome the EC resolution to increase the indication for brexpiprazole to incorporate adolescents aged 13 years and older, offering younger folks in Europe with one other much-needed remedy possibility.”
Johan Luthman, EVP and Head of Analysis & Improvement at Lundbeck, mentioned: “As we speak marks a serious milestone for younger sufferers, caregivers, and households navigating the complexities of schizophrenia. This approval is testomony to our dedication and unwavering assist to reduce the illness burden for sufferers and caregivers within the EU by offering a remedy possibility with confirmed efficacy and tolerability.”
Brexpiprazole is an atypical oral antipsychotic taken as soon as a day, modulating serotonin and dopamine methods. It was beforehand permitted within the European Union in 2018 for the remedy of grownup schizophrenia.
