Dainippon Sumitomo Pharma Co., Ltd. (“DSP”) (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited (“Takeda”) (Head Office: Osaka, Japan) today jointly announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a Positive Opinion for lurasidone for the treatment of schizophrenia in adults. Lurasidone is a once-daily oral treatment that is currently available in Switzerland, the United States and Canada having been approved for use by the respective regulatory authorities.
The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over 6 weeks. In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change. It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.
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 most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, Parkinsonism and dystonia.