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Otsuka, Lundbeck launch schizophrenia drug Abilify Maintena in Europe

Otsuka Pharmaceutical Europe (Otsuka) and H. Lundbeck have launched schizophrenia drug Abilify Maintena (aripiprazole) in Europe for treatment of patients with schizophrenia.

The move follows an approval from the European Commission in November 2013.

Currently, Abilify Maintena is available in several European countries and is progressing through the various Healthcare Authorities that provide access to patients.

Denmark is the first European country where the drug is fully reimbursed and accessible to people with schizophrenia, and more than 10 markets are expected to launch by the end of 2014.

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

In clinical trials, the drug provided protection from relapse over the long term with over 90% of patients remaining relapse-free at the end of the trial period.

Lundbeck senior vice president of International Markets and Europe Ole Chrintz said the company is happy 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," Chrintz said.

Otsuka Europe president and CEO Ole Vahlgren 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," Vahlgren said.

"We are committed to working with local governments and healthcare authorities to make Abilify Maintena available to patients in every European country."

In February 2013, FDA had approved Abilify Maintena for the treatment of schizophrenia in the US.

Abilify Maintena has recently received a marketing authorization for the maintenance treatment of schizophrenia in stabilized adult patients in Canada.