Aripiprazole's new long-acting injectable (LAI) formulation enables continuous exposure to medication for two months1.
Aripiprazole once-every-two-months LAI is a new formulation containing 960 mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution. It is intended for dosing once every two months via intramuscular injection into the gluteal muscle1 and is the first once-every-two-months LAI antipsychotic licensed in the EU for this indication.
Dr
'This approval represents an important step for patients, families, and healthcare providers. It reflects our commitment to addressing unmet medical needs through innovation. Specifically designed for adult patients with schizophrenia
Dr
'We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another, simplified, treatment regimen. We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and their healthcare practitioners to focus on other elements of care.'
About Abilify® (aripiprazole)
Aripiprazole is a dopamine D2 partial agonist and 5-HT1A partial agonist and a 5-HT2A receptor with antagonistic activity3. It is available as a daily oral tablet, orally disintegrating tablet, and oral solution (Abilify®), or a once-monthly LAI formulation (Abilify Maintena® 400 mg)3,4. Abilify® is also available as a short-acting intramuscular (IM) Injection3. Aripiprazole was discovered by Otsuka and is being co-developed and co-commercialised under a collaboration and license agreement between
About schizophrenia
Schizophrenia is a chronic, disabling and progressive mental illness, characterised by delusions, hallucinations, and disordered cognition which may occur at varying intervals between periods of relative symptomatic stability5. Schizophrenia affects approximately 24 million people, or 1 in 300 people (0.32%) worldwide6. Onset is most often during late adolescence and the twenties, and onset tends to happen earlier among men than women6. Schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other important areas of life6. It is one of the top 15 leading causes of disability worldwide7.
About Otsuka
Otsuka researches, develops, manufactures, and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health issue.
Otsuka Europe employs around 500 people and focuses on psychiatric and neurologic disorders, nephrology, haemato-oncology, rare diseases and digital medicines.
The Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately E13.6 billion and a spend of E2 billion on research and development in 2023. For further information on Otsuka, please visit www.otsuka-europe.com.
Otsuka contact for media
ARoss@Otsuka-Europe.com
+44 776 833 7128
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases. As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options. Our goal is to create long term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
We are 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. We have research facilities in
Lundbeck generated revenue of
For additional information, we encourage you to visit our corporate website www.lundbeck.com/global and connect with us on LinkedIn.
Lundbeck contacts
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Vice President, Investor Relations |
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References
- Harlin, M, et al. CNS Drugs 2023; doi: 10.1007/s40263-023-00996-8.
- Citrome, L, et al. J Clin Psychiatry 2023; doi:10.4088/JCP.23m14873.
- EMA. Abilify. Available from: https://www.ema.europa.eu/en/documents/product-information/abilify-epar-product-information_en.pdf [Accessed: March 2024].
- EMA. Abilify Maintena. Available from: https://www.ema.europa.eu/en/documents/product-information/abilify-maintena-epar-product-information_en.pdf [Accessed: March 2024].
- Kahn RS, et al. Nat Rev Dis Primers 2015; 1 (15067).
World Health Organisation . Factsheet, Schizophrenia. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia [Accessed: March 2024].-
Global Burden of Disease Study 2016.
Lancet 2017;390 (10100): 1211-1259.
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby,
+45 3630 1311
info@lundbeck.com
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