NDA Approved for Long-Acting Injectable for Schizophrenia and Bipolar I

MohamadFaizal/AdobeStock

The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for aripiprazole (Abilify Asimtufii) 2-month, ready-to-use, extended-release injectable for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. This is the first 2-month LAI antipsychotic indicated for both the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in the United States.^1,2

“We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder,” said John Kraus, MD, PhD, chief medical officer and executive vice president at Otsuka.

One dose of this long-acting injectable provides 2 months of sustained therapeutic concentrations. Doses are provided in a single-chamber, prefilled syringe of either 960 mg or 720 mg, and are administered by a health care professional via gluteal muscle intramuscular injection. Concentrations of aripiprazole were investigated in a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients with schizophrenia and bipolar I disorder.

“This approval is important news for patients, families, and health care providers. We hope that the use of Abilify Asimtufii in treatment plans will have a positive impact on those living with schizophrenia or bipolar I disorder,” said Johan Luthman, executive vice president at Lundbeck. “We are grateful to the patients and researchers who made this major milestone possible.”

References

1. FDA approves Otsuka and Lundbeck’s Abilify Asimtufii® (aripiprazole), the first once-every-two-months long-acting injectable (LAI) for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults. Otsuka. News release. April 27, 2023. Accessed April 28, 2023. https://www.otsuka-us.com/news/fda-approves-otsuka-and-lundbecks-abilify-asimtufiir-aripiprazole-first-once-every-two-months

2. Kuntz L. NDA for long-acting injectable for schizophrenia and bipolar I accepted. Psychiatric Times. September 13, 2022. https://www.psychiatrictimes.com/view/nda-for-long-acting-injectable-for-schizophrenia-and-bipolar-i-accepted