Otsuka and Lundbeck seek EU approval of schizophrenia therapy

Otsuka and Lundbeck have announced the submission of a collaboratively-developed schizophrenia therapy for European regulatory approval.

A marketing authorisation application for the companies' new aripiprazole depot formulation has been filed with the European Medicines Agency, seeking approval of the drug as a maintenance treatment for adult schizophrenia patients.

It is the first dopamine D2 partial agonist submitted in Europe as a once-monthly injection and will help address the need for relapse prevention among sufferers of the psychological disorder, with clinical study data supporting its safety and efficacy.

This comes as part of a collaborative agreement between Otsuka and Lundbeck signed in November 2011 that will see the organisations working to develop up to five compounds together.

Dr William Carson, president and chief executive officer for Otsuka's pharmaceutical development and commercialisation division, said: "If approved, more patients with schizophrenia will have access to the efficacy and safety profile of aripiprazole in a once-monthly formulation."

Last month, the company announced a new business alliance with Pioneer that will involve the joint development of an innovative endoscope for medical use.