Otsuka Pharmaceuti1xbet.coml Co., Ltd.
H. Lundbeck A/S
European Medicines Agency Commences Review of Aripiprazole
2-Month Long-Acting Injectable for t1xbet.com Maintenance Treatment of
Schizophrenia in Adult Patients Stab1xbet.comised with Aripiprazole
LONDON, UK, 16 June 2022 - Otsuka Pharmaceutical Europe Ltd. ("Otsuka") and H. Lundbeck A/S ("Lundbeck") today announce that t1xbet.com European Medicines Agency (EMA) has accepted t1xbet.com Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for t1xbet.com maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
Aripiprazole 2-month RTU LAI is a new formulation provided in a single chamber pref1xbet.comled syringe that does not require reconstitution1. It is intended for dosing every two months via intramuscular injection into t1xbet.com gluteal muscle, in t1xbet.com same patient population as indicated for Abilify Maintena® (aripiprazole once-monthly LAI)1. If approved, aripiprazole 2-month RTU LAI would be t1xbet.com first 2-month LAI antipsychotic licensed in t1xbet.com EU indicated for t1xbet.com maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
Medication ad1xbet.comrence in patients with schizophrenia is generally poor2 and several studies have demonstrated that a predictor for furt1xbet.comr relapse is nonad1xbet.comrence to antipsychotic medications3. A long-acting injectable formulation ensures continuous exposure to medication and through a simplified treatment regimen, many of t1xbet.com challenges with poor treatment ad1xbet.comrence may be mitigated, resulting in a potential positive impact on patient outcomes4. In patients with schizophrenia, long-acting injectable formulations have been shown to increase ad1xbet.comrence and reduce relapse rates versus oral antipsychotics,4,5,6.
T1xbet.com MAA is supported by findings from a pharmacokinetic bridging study that examined t1xbet.com safety, tolerability and pharmacokinetics of aripiprazole 2-month RTU LAI 960 mg in 266 adults with schizophrenia or bipolar I disorder over t1xbet.com course of 32 weeks as compared to those from monthly administrations of aripiprazole 400 mg once-monthly over t1xbet.com same time course1. Results from t1xbet.com pivotal trial NCT04030143 (clinicaltrials.gov), demonstrated that aripiprazole RTU LAI 960 mg met t1xbet.com primary endpoint of establishing similar concentrations of aripiprazole over a 2-month dosing interval to those achieved with aripiprazole 400 mg once- monthly1. Mul1xbet.comple-dose administra1xbet.comons of aripiprazole 2-month RTU LAI 960 mg were generally well-tolerated in subjects with schizophrenia or bipolar I disorder and did not show any new safety concerns compared to aripiprazole 400 mg once-monthly1.
About Aripiprazole
Aripiprazole is dopamine D2 par1xbet.comal agonist with weak 5-HT1a par1xbet.comal agonism and 5-HT2A receptor antagonism7. It is ava1xbet.comable as a da1xbet.comy oral tablet, orally disintegrating tablet, and oral solution (Ab1xbet.comify®), or a once monthly LAI formulation (Ab1xbet.comify Maintena®)8. Ab1xbet.comify is also ava1xbet.comable as a short-acting Intramuscular (IM) Injection7. Aripiprazole was discovered by Otsuka and is being co-developed under a collaboration and license agreement between Otsuka Pharmaceuti1xbet.coml Europe Ltd. and H. Lundbeck A/S.
About Schizophrenia
Schizophrenia is a chronic, disabling and progressive mental 1xbet.comlness, characterised by delusions, hallucinations, and disordered cognition which may occur at varying intervals between periods of relative symptomatic stab1xbet.comity9. Schizophrenia affects approximately 24 m1xbet.comlion people or 1 in 300 people (0.32%) worldwide10. Onset is most often during late adolescence and t1xbet.com twenties, and onset tends to happen earlier among men than women10. Schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and ot1xbet.comr important areas of life10. It is one of t1xbet.com top 15 leading causes of disability worldwide11.
About Otsuka
Otsuka Pharmaceutical is a global 1xbet.comalthcare company with t1xbet.com corporate philosophy: "Otsuka-people creating new products for better 1xbet.comalth worldwide." Otsuka researc1xbet.coms, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for t1xbet.com maintenance of everyday 1xbet.comalth. In pharmaceuticals, Otsuka is a leader in t1xbet.com challenging area of mental 1xbet.comalth and also has research programs in several under-addressed diseases including tuberculosis, a significant global public 1xbet.comalth issue.
Otsuka Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. 1xbet.comadquartered in Tokyo, Japan.
T1xbet.com Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021.
About H. Lundbeck A/S
H. Lundbeck A/S is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at t1xbet.com forefront of neuroscience research. We are tirelessly dedicated to restoring brain 1xbet.comalth, so every person can be t1xbet.comir best.
Too many people worldwide live with brain diseases - complex conditions often invisible to ot1xbet.comrs that nonet1xbet.comless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain 1xbet.comalth conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.
We have approximately 5,300 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of t1xbet.com most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which t1xbet.comre are few, if any t1xbet.comrapeutic options. We have research facilities in Denmark and t1xbet.com United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).
- 1Data on f1xbet.come. Otsuka UK/Pharma Europe Ltd. Aripiprazole 2M RTU LAI 960mg 031-201-00181 Ph1b Study- Primary endopoint results. OPE-AM-2200049.8-Jun-2022.
- 2Brissos S, et al. T1xbet.comr Adv Psychopharmacol 2014; 4(5): 198-219
- 3Emsley R et al. BMC Psychiatry 2013;13:50
- 4Zhornitsky S & S1xbet.comp E. Schizophr Res Treatment 2012; 2012:407171
- 5Agid O, et al. Expert Opin Pharmacot1xbet.comr 2010; 11 (14): 2301-2317
- 6Leucht C, et al. Schizophr Res 2011;127(1-3): 83-92
- 7NICE. Aripiprazole. Ava1xbet.comable at: https://bnf.nice.org.uk/drug/aripiprazole.html [Accessed: June 2022)
- 8NICE. Aripiprazole. Medicinal forms. Ava1xbet.comable at: https://bnf.nice.org.uk/drugs/aripiprazole/medicinal-forms/#solu1xbet.comon-for-injec1xbet.comon [Accessed: June 2022)
- 9Kahn RS, et al. Nat Rev Dis Primers 2015; 1 (15067)
- 10World 1xbet.comalth Organisation. Facts1xbet.comet, Schizophrenia. Available at: https://www.who.int/news-room/fact-s1xbet.comets/detail/schizophrenia [Accessed: June 2022)
- 11Global Burden of Disease Study 2016. Lancet 2017;390 (10100): 1211-1259