CHMP recommends approval of Latuda for Schizophrenia - Takeda

The EMA's CHMP has issued a Positive Opinion for Latuda (lurasidone), from Dainippon Sumitomo Pharma and Takeda, for the treatment of Schizophrenia in adults. 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. 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.