Lundbeck and Otsuka initiate European launch of Abilify Maintena®, a once-monthly formulation for the treatment of schizophrenia

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka) today announced the launch of Abilify Maintena in Europe following approval by the European Commission in November 2013. Abilify Maintena is now available in a number of European countries and is progressing through the various Healthcare Authorities that provide access to patients. Denmark is the first European country where Abilify Maintena is fully reimbursed and accessible to people with schizophrenia, and more than ten markets are expected to launch by the end of 2014.

Abilify Maintena (aripiprazole) is an intramuscular (IM), once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

In clinical trials, Abilify Maintena provided protection from relapse over the long term with over 90% of patients remaining relapse-free at the end of the study period^1,2. It offers long-term control of positive and negative symptoms and can help preserve patients’ personal and social functioning while offering a favourable tolerability profile similar to oral aripiprazole.

“We are very pleased to bring once-monthly Abilify Maintena to people diagnosed with schizophrenia” said Ole Chrintz, Senior Vice President, International Markets and Europe at Lundbeck. “Patients early in the course of their disease may have the most to gain from a long-acting treatment that reduces their risk of relapse over the long term and can help them maintain personal and social functioning.”

Ole Vahlgren, CEO & President, Otsuka Europe noted “The clinical and economic burden of schizophrenia is substantial. The majority of patients who try long-acting injections tend to prefer them over their previous oral formulations. We are committed to working with local governments and healthcare authorities to make Abilify Maintena available to patients in every European country”.

Abilify Maintena was approved by the FDA for the treatment of schizophrenia in the US in February 2013 and has recently received a marketing authorization for the maintenance treatment of schizophrenia in stabilized adult patients in Canada.

Reference

1. Kane, JM et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-624.
2. Fleischhacker WW, Sanchez R, Perry PP, et al. Aripiprazole once-monthly for the treatment of schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of the American Psychiatric Association, 18–22 May, 2013 (poster)