The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) had already issued a positive opinion for Latuda in January 2014.
Latuda is an atypical antipsychotic agent, developed by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects.
The European approval was based on a comprehensive clinical trial program of eight positive trials, which included placebo and active comparators.
The review also included more than 50 clinical trials and over 4,500 lurasidone-treated subjects, which showed that the drug to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia.
Lurasidone also showed a statistically significant separation from placebo seen as early as day four on primary efficacy measures in some major trials in schizophrenia.
The most frequent adverse reactions seen in short-term clinical studies were somnolence, akathisia, nausea, parkinsonism and dystonia.
The trials have shown that lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia.
The drug also showed significant reductions in mean weight and BMI over 12 months in contrast to increases in risperidone-treated patients.
Latuda is marketed by Sunovion Pharmaceuticals Europe, a subsidiary of DSP in the UK and by Takeda subsidiaries across Europe.