Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (NDA217006, ORIG 1, 2023)

Otsuka Holdings Co., Ltd. · 2023 · FDA Review (openFDA) · company profile →

Report summary

Otsuka Holdings Co., Ltd. submitted NDA 217006 for Abilify Asimtufii (aripiprazole) injection, a 2-month long-acting injectable for schizophrenia and bipolar I disorder. The FDA recommends approval based on a pharmacokinetic (PK) bridge to Abilify Maintena, eliminating the need for new efficacy trials. Nonclinical studies showed no new toxicities. The application relies on previous Abilify approvals for safety and efficacy, supported by a pivotal PK bridging study (031-201-00181) and two smaller studies. The safety profile, including adverse events and specific concerns, is consistent with Abilify Maintena. PK parameters of the 960 mg dose were similar to the 400 mg IM depot, confirmed by a population PK model. The PDUFA goal date is April 27, 2023.

Key findings — cited to the page

Recommended Indication(s)/Population(s)	Schizophrenia, Bipolar Disorder	· p.2
Submit Date	6/27/2022	· p.2
Received Date	6/27/2022	· p.2
PDUFA Goal Date	4/27/2023	· p.2
Priority or Standard	Standard	· p.2
Application Type	Original NDA	· p.2
Application Number	217006	· p.2
Review Completion Date	4/27/2023	· p.2
Applicant Proposed Dosing Regimen	Every 2 months	Abilify Asimtufii · p.2
Applicant Proposed Indication(s)/Population(s)	Treatment of schizophrenia and as a maintenance monotherapy treatment of bipolar I disorder	Abilify Asimtufii · p.2
Recommendation on Regulatory Action	Approval	· p.2
Recommended Dosing Regimen	960 mg administered once every two months as a single injection; dose can be reduced to 720 mg in patients with adverse reactions	· p.2

Source: Otsuka Holdings Co., Ltd. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →