Lundbeck and Otsuka today announced a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.
“Abilify Maintena has been available in the US for some six months with encouraging feedback from patients and physicians, and we now look forward to launching this important treatment alternative together with our partner into the psychiatric community in Europe as well”, said Ole Chrintz, Senior Vice President, International Markets & Europe at Lundbeck. “Abilify Maintena represents an important treatment option for patients, their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia”.
“I am delighted that we now have a positive opinion for Abilify Maintena from the CHMP and if approved will be able to provide European patients with a long-term maintenance option for schizophrenia,” said Ole Vahlgren, CEO & President, Otsuka Europe.
The efficacy of Abilify Maintena was demonstrated in two double-blind, randomised phase III trials over 38 and 52 weeks respectively. In the primary pivotal trial analysis of the primary efficacy endpoint, the proportion of patients experiencing impending relapse by the end of week 26, demonstrated non-inferiority of Abilify Maintena to oral aripiprazole and superiority to a sub-therapeutic dose of aripiprazole once monthly1. The key secondary endpoint, time to relapse, supported the efficacy in maintenance treatment.
In the second efficacy trial, Abilify Maintena significantly delayed time to relapse compared to placebo (primary efficacy endpoint)2. In a key secondary endpoint, the percentage of subjects experiencing relapse was also significantly lower with Abilify Maintena compared to placebo at the end of the study. The safety profile for Abilify Maintena was comparable to oral Abilify1.The most common side effects are weight gain, akathisia (restlessness), insomnia (difficulty in sleeping), injection site pain.
On 11 November 2011, Otsuka and Lundbeck announced the formation of an alliance to collaborate on the development and commercialisation of up to five early and late stage compounds in development. Abilify Maintena is expected to be the first approved and commercialised product in the EU from the global alliance between the two companies, focused on developing Central Nervous System (CNS) therapies worldwide.
Lundbeck will make a milestone payment to Otsuka of USD 75 million upon the European Commission’s final approval of Abilify Maintena.