Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for Abilify Maintena (aripiprazole).
Abilify Maintena is a once-monthly injectable form of aripiprazole for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.
The drug's efficacy has been demonstrated in two double-blind, randomized Phase III trials over 38 and 52 weeks respectively and its safety profile was comparable to oral Abilify.
The benefits of Abilify Maintena are its capability of reducing the proportion of stabilized patients experiencing relapse in long term use and its properties to act as long acting agent, allowing a monthly administration instead of a daily oral intake of aripiprazole.
Aripiprazole's pharmacological properties are mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors.
Abilify Maintena, which has already obtained regulatory approval in the US, represents an alternative treatment option to address the need to reduce the risk of relapse (relative to placebo) in patients with schizophrenia.
Lundbeck International Markets & Europe senior vice president Ole Chrintz said: "Abilify Maintena has been available in the US for some six months with encouraging feedback from patients and physicians, and the company now looks forward to launching this important treatment alternative together with its partner into the psychiatric community in Europe as well."
Otsuka and Lundbeck formed a collaboration for the development and commercialization of up to five early and late stage compounds in development in November 2011.
Abilify Maintena will become the first commercialized product in the EU generated from the global alliance between the two companies, subject to EU approval.
Upon the European Commission's final approval of Abilify Maintena, Lundbeck will make a $75m milestone payment to Otsuka.
