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-months 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.
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.
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“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-months 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.”
In February 2024, Otsuka received breakthrough therapy designation for its rare kidney disease drug sibeprenlimab from the US Food and Drug Administration.
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