Otsuka Pharmaceutical Europe Ltd.

The drug is being jointly developed and commercialised through a partnership between Lundbeck and Otsuka. Credit: Longfin Media/Shutterstock. The European Commission (EC) has approved Otsuka Pharmaceutical and Lundbeck’s atypical oral antipsychotic Rxulti (brexpiprazole) for schizophrenia in adolescents aged 13 years and above. Schizophrenia is a progressive mental illness marked by disordered cognition. The decision expands the drug’s indication, which was previously approved for adult schizophrenia treatment within the European Union (EU) in 2018. The EC’s latest decision is supported by a randomised, six-week, double-blind, active-referenced and placebo-controlled trial involving 316 adolescent subjects. The study aimed to assess the safety and efficacy of the drug, with the primary outcome focusing on safety and the secondary on efficacy. Lundbeck research and development head and executive vice-president Johan Luthman said: “Today marks a major milestone for young patients, caregivers and families navigating the complexities of schizophrenia. “This approval is a testament to our commitment and unwavering support to lessen the disease burden for patients and caregivers in the EU, by providing a treatment option with proven efficacy and tolerability.” Subjects of the given age group who received the drug, at dosages between two and four milligrams per day, experienced a significant decrease in the severity of their symptoms. These improvements were measured using the Positive and Negative Syndrome Scale (PANSS) total score against a placebo. The therapy was generally well-tolerated, exhibiting a safety profile consistent with that observed in adults with schizophrenia. Brexpiprazole is administered once daily and was discovered by Otsuka. It is being jointly developed and commercialised through a partnership and licence agreement between Lundbeck and Otsuka Pharmaceutical Europe. Otsuka Pharmaceutical Europe CEO Andy Hodge stated: “The prognosis for adolescence-onset schizophrenia is poor compared with adult-onset schizophrenia and can be associated with more chronic and severe symptoms.”

RSS Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older1 Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 20252 Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo3 Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the European Commission (EC) has approved Rxulti® (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.1 Brexpiprazole was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.4 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.3 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.3 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." About Rxulti® (brexpiprazole) Brexpiprazole is an atypical oral antipsychotic that is taken once a day.4 The pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at the serotonin and dopamine systems that combines partial agonist activity at serotonergic 5-HT1A and at dopaminergic D2 receptors with antagonist activity at serotonergic 5-HT2A receptors, with similar high affinities at all of these receptors. Brexpiprazole also shows antagonist activity at noradrenergic α1B/2C receptors with affinity in the same sub-nanomolar Ki range.4,5 Brexpiprazole was discovered by Otsuka and is being co-developed and co-commercialised under a collaboration and license agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S. Brexpiprazole was previously approved in the European Union in 2018 for the treatment of adult patients with schizophrenia.4 References

The treatment is indicated for adult schizophrenia patients who have been stabilised with aripiprazole. Credit: Ground Picture / Shutterstock.com. The European Commission (EC) has approved Otsuka Pharmaceutical Europe and H Lundbeck’s Abilify Maintena 720mg/960mg (aripiprazole) for the maintenance treatment of schizophrenia. The treatment is indicated for use in adult schizophrenia patients who have been stabilised with aripiprazole. The approval marks the introduction of the first once-every-two-month long-acting injectable (LAI) antipsychotic in the European Union (EU) for this indication. Designed for bi-monthly dosing through an intramuscular injection into the gluteal muscle, the new formulation of aripiprazole once every two months LAI is offered in a single-chamber prefilled syringe and does not need reconstitution. The EC’s decision extends to all EU member states, Norway, Iceland and Liechtenstein. See Also: China NMPA accepts Astellas’ sBLA for urothelial cancer treatment EC approves Merck’s KEYTRUDA regimen for NSCLC treatment Otsuka Europe medical affairs vice-president and head Dr Peter Gillberg stated: “We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another simplified treatment regimen. “We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and their healthcare practitioners to focus on other elements of care.” The approval was based on the results of a 32-week pharmacokinetic bridging clinical trial. This study also assessed the safety and efficacy of Abilify Maintena as primary and secondary endpoints respectively. The once-every-two-month LAI formulation demonstrated plasma concentrations, effectiveness, safety and tolerability profiles in line with the established once-monthly LAI (Abilify Maintena 400mg) dose in 266 adult subjects, 185 of whom were diagnosed with schizophrenia. Lundbeck research and development executive vice-president and head Dr Johan Luthman stated: “Specifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient adherence and convenience, contributing to the careful and comprehensive management of this chronic condition.” Last month, Otsuka received breakthrough therapy designation for its rare kidney disease drug sibeprenlimab from the US Food and Drug Administration.