The European Commission has given the green light to Otsuka Pharmaceutical Co and Lundbeck’s Abilify Maintena for schizophrenia.
Abilify Maintena is a once-monthly, long-acting injectable version of the oral blockbuster Abilify (aripiprazole). Specifically it has been approved as maintenance treatment of schizophrenia in adults stabilised with oral aripiprazole.
The drug has a tolerability profile similar to oral aripiprazole, and has demonstrated statistically significant benefits on patients’ personal and social functioning as compared to placebo. The companies said that 93% of patients treated with Abilify Maintena were “extremely, very or somewhat satisfied” with the drug at the end of the double-blind treatment phase.
Otsuka and Lundbeck noted that the therapy is the only dopamine D2 partial agonist in a once-monthly, injectable form to receive marketing authorisation in Europe for maintenance treatment of schizophrenia. It is also the first commercialised product in Europe to come out of the firms’ global central nervous system alliance.
Ole Chrintz, head of international markets and Europe at Lundbeck, said studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse. He added that “efficacy is important, but a treatment for a chronic condition such as schizophrenia also needs to be well tolerated so patients will stay on it over the long-term”.
