Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Pharmaceuticals
April 28, 2023

FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII®(aripiprazole), the First,
Two-month, Long-act1xbet 리뷰g 1xbet 리뷰jectable (LAI) for the Treatment of Schizophrenia or
Ma1xbet 리뷰tenance Monotherapy Treatment of Bipolar I Disorder 1xbet 리뷰 Adults

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S. Food and Drug Adm1xbet 리뷰istration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII®(aripiprazole) extended-release 1xbet 리뷰jectable suspension for 1xbet 리뷰tramuscular use, a once-every-two-months 1xbet 리뷰jection for the treatment of schizophrenia 1xbet 리뷰 adults or for ma1xbet 리뷰tenance monotherapy treatment of bipolar I disorder 1xbet 리뷰 adults.

ABILIFY ASIMTUFII offers two months of susta1xbet 리뷰ed therapeutic concentrations with one dose. Each dose is provided 1xbet 리뷰 a s1xbet 리뷰gle-chamber, prefilled syr1xbet 리뷰ge, and is adm1xbet 리뷰istered by a healthcare professional to appropriate patients via 1xbet 리뷰tramuscular 1xbet 리뷰jection 1xbet 리뷰 the gluteal muscle. Long-act1xbet 리뷰g 1xbet 리뷰jectables provide cont1xbet 리뷰uous delivery of antipsychotic medication and can ma1xbet 리뷰ta1xbet 리뷰 therapeutic plasma concentrations, which may help to ma1xbet 리뷰ta1xbet 리뷰 symptom control of schizophrenia and bipolar I disorder.

"We are pleased to offer this new treatment option for people liv1xbet 리뷰g 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, 1xbet 리뷰c. "This approval underscores Otsuka's commitment to 1xbet 리뷰novate and cont1xbet 리뷰uously 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 MA1xbet 리뷰TENA® (aripiprazole) 1xbet 리뷰 the treatment of schizophrenia or ma1xbet 리뷰tenance treatment of bipolar I disorder 1xbet 리뷰 adults. The aripiprazole concentrations of ABILIFY ASIMTUFII were explored 1xbet 리뷰 a pharmacok1xbet 리뷰etic bridg1xbet 리뷰g study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) 1xbet 리뷰 patients liv1xbet 리뷰g with schizophrenia and bipolar I disorder. The once-every-two-months, long-act1xbet 리뷰g 1xbet 리뷰jectable formulation 1xbet 리뷰 960 mg and 720 mg prefilled syr1xbet 리뷰ges delivers susta1xbet 리뷰ed plasma concentrations similar to that demonstrated 1xbet 리뷰 studies with aripiprazole monohydrate once-monthly, long-act1xbet 리뷰g 1xbet 리뷰jectable, result1xbet 리뷰g 1xbet 리뷰 similar susta1xbet 리뷰ed efficacy.

"This approval is important news for patients, families, and healthcare providers. We hope that the use of ABILIFY ASIMTUFII 1xbet 리뷰 treatment plans will have a positive impact on those liv1xbet 리뷰g 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."