The European Commission (EC) has approved Otsuka and Lundbeck’s Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older. Brexpiprazole was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.
The EC based its approval on a 6-week, randomised, double-blind placebo-controlled and active-referenced trial of 316 adolescent patients, which evaluated the efficacy and safety profile of the drug as primary and secondary outcomes, respectively. Brexpiprazole (2-4mg/day) was associated with greater reductions in symptom severity, as measured by the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo in patients aged 13 years and older, and was generally well tolerated with a safety profile consistent with that seen in adult patients with schizophrenia.
Andy Hodge, CEO at Otsuka Pharmaceutical Europe, said: “The prognosis for adolescence-onset schizophrenia is poor compared with adult-onset schizophrenia and can be associated with more chronic and severe symptoms. We welcome the EC decision to extend the indication for brexpiprazole to include adolescents aged 13 years and older, providing young people in Europe with another much-needed treatment option.”
Johan Luthman, EVP and Head of Research & Development at Lundbeck, said: “Today marks a major milestone for young patients, caregivers, and families navigating the complexities of schizophrenia. This approval is testament to our commitment and unwavering support to lessen the disease burden for patients and caregivers in the EU.”
