Otsuka and Lundbeck have taken a step toward approval of their two-month, ready-to-use, long-acting injectable treatment for schizophrenia and bipolar I disorder, securing FDA acceptance of the filing and an April 27 PDUFA date.
The approval application covers the same patient populations as indicated for Abilify Maintena, Otsuka and Lundbeck’s existing once-monthly treatment. In a phase 1/2 clinical trial, Otsuka compared its new two-month long-acting injectable to its one-month depot therapy in 266 patients, emerging with data to show the formulations yield similar aripiprazole plasma concentrations.
In recent months, Otsuka and Lundbeck have embarked on a push to bring the two-month treatment to market, securing acceptance of an application for review by the European Medicines Agency in June and following up with the initiation of the FDA’s assessment this week.
The FDA action puts the partners on course to win approval for the formulation in the U.S. by April 27. Robert McQuade, Ph.D, executive vice president and chief strategy officer at Otsuka, set out what the approval would mean for patients.
“Stability is critical for patients with schizophrenia and bipolar I, which means delaying time to relapse or recurrence and supporting their role as functioning members of their community. As we continue our efforts to bring aripiprazole 2-month to market, we remain committed to our patients and confident that the favorable safety and tolerability profile will be clearly visible,” McQuade said in a statement.
The candidate is part of a broader shift toward long-acting injectable treatments of schizophrenia, which has seen Johnson & Johnson rack up billions of dollars in annual sales for its portfolio of treatments.