EU approves long-acting injectable for schizophrenia

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Abilify Maintena 960mg (aripiprazole) has been approved in the EU as the first once-every- two-months long-acting injectable for the maintenance treatment of schizophrenia.

The new long-acting injectable (LAI) formulation enables continuous exposure to medication for two months.

Aripiprazole once-every-two-months LAI is a new formulation containing 960mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution.

The EC based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated the safety and efficacy of the drug as primary and secondary endpoint respectively.

Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Maintena 400mg) in 266 adults, of whom 185 were diagnosed with schizophrenia.

Dr Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck, said: “This approval represents an important step for patients, families, and healthcare providers. It reflects our commitment to addressing unmet medical needs through innovation. 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.”

Dr Peter Gillberg, Vice President and Head of Medical Affairs at Otsuka Europe, added: “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.”

Diana Spencer, Senior Digital Content Editor, DDW

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