Abilify Asimtufii (aripiprazole) injection
Psychiatry· 216 cited findings· 1 source document
Company: Otsuka Holdings Co., Ltd.
What the regulatory reviews say
Abilify Asimtufii (aripiprazole) injection is an original New Drug Application (NDA 217006) submitted on June 27, 2022, with a Standard Priority review. The PDUFA Goal Date and Review Completion Date were April 27, 2023. The applicant proposed a dosing regimen of every 2 months.
Efficacy findings indicate that steady-state exposures of aripiprazole are similar. Safety data from dog studies showed that Aripiprazole 2M RTU LAI IM administration was well tolerated at a dose of 420 mg/animal over 52 weeks, with a 26-week recovery period. White blood cell increases of 60% were observed on Day 2 in drug-treated dogs. Nonfatal Serious Adverse Events (SAEs) were reported at 6% and 4%. Aripiprazole 2M RTU LAI PK changes with stress factors were less than 2-fold, and tmax prolongation with diclofenac was 2.8 days. Abilify Maintena has a dose of 960 mg for an extended dosing interval.
The trial design included one pivotal PK bridging and safety study and two supporting PK and safety studies. Aripiprazole 2M RTU LAI concentration is 300 mg/mL, while Abilify Maintena concentration is 200 mg/mL. A single IM dose in rats was 50 mg/kg. Study 031-201-00279 Part A (single-dose group) included 24 subjects.
Key figures — cited to the source page
| Nonfatal Serious Adverse Events (SAEs) | 6 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.97 |
| Nonfatal Serious Adverse Events (SAEs) | 4 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.97 |
| White blood cell increase on Day 2 in drug-treated dogs | 60 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.37 |
| PDUFA Goal Date | 4/27/2023 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.2 |
| Review Completion Date | 4/27/2023 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.2 |
| Application Number | 217006 | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.2 |
| Applicant Proposed Dosing Regimen | Every 2 months | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.2 |
| Priority or Standard | Standard | Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (ND, p.2 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.