US FDA approves Otsuka & Lundbecks Abilify Asimtufii, the first, two-month, LAI to treat schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Abilify Asimtufii (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. Abilify Asimtufii offers two months of sustained therapeutic concentrations with one dose. Each dose is provided in a single-chamber, prefilled syringe, and is administered by a healthcare professional to appropriate patients via intramuscular injection in the gluteal muscle. Long-acting injectables provide continuous delivery of antipsychotic medication and can maintain therapeutic plasma concentrations, which may help to maintain symptom control of schizophrenia and bipolar I disorder. "We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder that may delay the time to relapse," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc. "This approval underscores Otsuka's commitment to innovate and continuously evolve to meet the needs of the communities we serve." The efficacy of Abilify Asimtufii Is based on the adequate and well-controlled studies of Abilify Maintena (aripiprazole) in the treatment of schizophrenia or maintenance treatment of bipolar I disorder in adults. The aripiprazole concentrations of Abilify Asimtufii were explored in a pharmacokinetic bridging study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients living with schizophrenia and bipolar I disorder. The once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations similar to that demonstrated in studies with aripiprazole monohydrate once-monthly, long-acting injectable, resulting in similar sustained efficacy. "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," said Johan Luthman, executive vice president, R&D, Lundbeck. "We are grateful to the patients and researchers who made this major milestone possible." Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition. Based on a systematic review of global data, the prevalence of schizophrenia in 2019 was estimated to be approximately 0.3% and did not vary widely across countries or regions. The worldwide lifetime prevalence of the disease has been estimated to be approximately 0.9% across diverse geographic, cultural, and socioeconomic categories. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviors occurring at varying intervals between periods of relative symptomatic stability. Bipolar I disorder is a recurrent, lifelong mood disorder with a variable course that results in functional and cognitive impairment and a reduction in quality of life that affects 0.6% of the population. The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months. Over 90% of people with bipolar disorder experience recurrences during their lifetimes. Bipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence. Long-acting injectables have the potential to provide continuous delivery of antipsychotic medication and can maintain therapeutic plasma concentrations, which may help address the variable nature of bipolar disorder. Abilify Asimtufii (aripiprazole), once-every-two-months, long-acting injectable, is provided in a single-chamber, prefilled syringe (PFS) that does not require reconstitution. It is intended for dosing once-every-two-months via intramuscular (IM) injection in the gluteal muscle in the same patient populations as indicated for once-monthly Abilify Maintena. Results from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that Abilify Asimtufii 960 mg met the primary endpoint criteria establishing similarity of aripiprazole plasma concentrations and thus comparable effectiveness to Abilify Maintena 400 mg over a two-month dosing interval. Multiple-dose administrations of abilify asimtufii once-every-two-months, LAI 960 mg were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder and showed comparable safety to aripiprazole once-monthly 400 mg. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka

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