H. Lundbeck A/S and Otsuka Pharmaceutical Europe Ltd. announced the European launch of Abilify Maintena (aripiprazole) following the approval by the European Commission last November 2013.
Denmark is the first European country where the drug is available and fully reimbursed to patients with schizophrenia. Abilify Maintena is also now marketed in several European countries and is currently under process through various Healthcare Authorities to provide access to patients. Abilify Maintena is expected to launch in ten more markets by the end of the year.
Ole Chrintz, Senior Vice President of the International Markets and Europe at Lundbeck, said “We are very pleased to bring once-monthly Abilify Maintena to people diagnosed with schizophrenia. 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.”
Scizophrenia is a chronic mental disease characterized by distorted processes in thinking and emotional responsiveness. The disease is commonly manifested through hallucinations, disorganized speech and mental processes, paranoid delusions. It is also accompanied by marked social and occupational dysfunction. Onset of symptoms usually occurs in young adulthood and often requires lifelong treatment to mitigate symptoms.
Relapse of the disease occurs when an exacerbation or acute psychotic outbreak is characterized mainly by positive symptoms such as hallucinations and delusions. A number of factors cause schizophrenic relapse. These include failure to response to antipsychotic medication, failure to take medication as prescribed, or when patients stop taking their medication altogether.
Abilify Maintena is a dopamine D2 partial agonist in once-monthly, injectable form to be granted marketing authorization for maintenance treatment for schizophrenia. The drug is indicated for maintenance treatment of schizophrenia in adults taking oral aripiprazole. Abilify Maintena is administered as a prolonged release suspension for intra-muscular injection. The drug has a tolerability profile similar to oral Abilify (aripiprazole).
Ole Vahlgren, CEO and President of Otsuka Europe, said “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.”