EU approves Latuda for Schizophrenia - Takeda

The European Commission has granted Marketing Authorization for once-daily oral Latuda (lurasidone), from Takeda, for the treatment of Schizophrenia in adults. The Marketing Authorization was based on a comprehensive clinical trial program of eight positive studies, which included placebo and active comparators. The review also contained more than 50 clinical trials and more than 4,500 lurasidone-treated subjects. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia.

In short and long 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. Clinical studies 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.