Otsuka, Lundbeck gain FDA nod for longer-acting version of schizophrenia drug Abilify

Longer-acting formulas have made the treatment of schizophrenia more convenient and reliable for patients. Now, stepping to the plate with another long-acting treatment are Otsuka and Lundbeck.

On Thursday, the FDA signed off on Abilify Asimtufii, an extended-release, injectable suspension administered every two months. The drug is for treating adults with schizophrenia and for maintenance in adults with bipolar I disorder.

Abilify Asimtufii gained the approval by showing in a trial of 266 schizophrenia and bipolar patients that it delivered plasma concentrations comparable to those provided by Abilify Maintena, the companies’ predecessor, which was approved for schizophrenia in 2013 and bipolar I disorder in 2017.

Abilify Asimtufii has also shown comparable safety and efficacy to Abilify Maintena, which is administered monthly at 400 mg.

The new Abilify comes in a single-chamber, prefilled syringe at 960 mg and 72 mg doses. It's administered by a healthcare professional by way of gluteal muscle injection.

Lundbeck listed (PDF) 2022 sales of Abilify Maintena at DKK 2,964 million ($419 million), a 20% increase from 2021.

The first version of Abilify (aripiprazole) was approved in the U.S. in 2002. Aripiprazole is a second-generation antipsychotic, which rebalances dopamine and serotine to improve mood and behavior.

Elsewhere in the industry, Johnson & Johnson has won FDA approval for long-acting schizophrenia drugs that sustain for three and six months. Last year, drugs in J&J’s Invega Sustenna and Invega Trinza franchise racked (PDF) up sales of $4.1 billion.