Otsuka and Lundbeck receive NDA approval from FDA for Abilify Asimtufii

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.

Abilify Asimtufii is a long-acting, extended-release injectable suspension offering sustained therapeutic concentrations via one dose every two months through intramuscular injection in the gluteal muscle.

It offers continuous delivery of medication and maintains therapeutic plasma concentrations.

Otsuka stated that the therapy is contraindicated in patients with a known hypersensitivity reaction to aripiprazole and is not approved to treat dementia-related psychosis in patients.

Otsuka executive vice-president and chief medical officer John Kraus stated: “We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder.

“This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.”

Abilify Asimtufii’s efficacy is based on the well-controlled trial of Abilify Maintena (aripiprazole) to treat schizophrenia or for maintenance treatment of bipolar I disorder in adult patients.

Its aripiprazole concentrations were explored in a multiple-dose, 32-week, parallel-arm, multicentre, open-label, randomised, pharmacokinetic bridging trial, which was conducted in 266 schizophrenia and bipolar I disorder patients.

Lundbeck research and development executive vice-president Johan Luthman stated: “This approval is important news for patients, families and healthcare 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.”

Lundbeck and Otsuka also signed an agreement for the development and commercialisation of five products related to psychiatry, including aripiprazole depot formulation and OPC-34712 from Otsuka.