Rxulti receives approval for Schizophrenia in adolescents in Europe

UK— The European Commission (EC) has approved Rxulti (brexpiprazole), an atypical oral antipsychotic developed by Otsuka Pharmaceutical and H. Lundbeck A/S, to treat schizophrenia in adolescents aged 13 and older in the UK.

This decision represents a significant broadening of the drug’s indications, as it was previously approved only for adult patients with schizophrenia in the European Union since 2018.

Schizophrenia is a chronic and debilitating mental disorder marked by symptoms such as delusions, hallucinations, and disordered thinking.

It affects roughly 24 million people around the globe, often surfacing during late adolescence or early adulthood.

The onset of schizophrenia in adolescents can be particularly challenging, as it typically presents with more severe and chronic symptoms compared to cases that begin in adulthood.

A thorough clinical trial informed the EC’s decision to approve Rxulti for younger patients. This six-week, randomized, double-blind, placebo-controlled study involved 316 adolescent participants and aimed to assess the safety and efficacy of brexpiprazole.

While safety was the primary focus, the trial also evaluated efficacy as a secondary outcome.

The results showed that brexpiprazole significantly alleviated the severity of schizophrenia symptoms in adolescents, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, compared to a placebo.

It was administered in doses ranging from 2 to 4 milligrams per day and was generally well-tolerated, with a safety profile similar to that observed in adult patients.

This approval is a major milestone for young patients, their caregivers, and families grappling with schizophrenia’s complexities.

Johan Luthman, Executive Vice President and Head of Research and development at Lundbeck, reaffirmed the company’s dedication to supporting patients and caregivers in the EU by offering a treatment option that has demonstrated efficacy and tolerability.

Andy Hodge, CEO of Otsuka Pharmaceutical Europe, emphasized the importance of this development, noting that schizophrenia that begins in adolescence often presents a poorer prognosis compared to adult-onset cases.

He welcomed the EC’s decision, which offers young people in Europe another much-needed treatment option.

Brexpiprazole functions as an atypical antipsychotic by modulating the serotonin and dopamine systems in the brain.

It serves as a partial agonist at the serotonergic 5-HT1A and dopaminergic D2 receptors, while also acting as an antagonist at the serotonergic 5-HT2A receptors.

 Additionally, it displays antagonist activity at noradrenergic α1B/2C receptors. This intricate mechanism of action aids in effectively managing schizophrenia symptoms.

 The drug is taken once daily, making it a convenient choice for patients.

Otsuka discovered Brexpiprazole, which is co-developed and co-commercialized through a collaboration and licensing agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S.

This partnership highlights the commitment of both companies to advancing mental health treatments and providing effective solutions for patients across various age groups.

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