IQWiG finds benefits of Latuda in Schizophrenia unproven-Takeda

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Latuda (lurasidone), from Takeda, offers an added benefit over the appropriate comparator therapy for the treatment of adults with Schizophrenia. From the dossier, lurasidone in the acute treatment was investigated in three comparative studies and compared with risperidone, olanzapine or quetiapine XR. However, the dosages of lurasidone and of the appropriate comparator therapies deviated from the guideline and the respective Summary of Product Characteristics. It is uncertain whether this led to a potential over- or underestimation of effects.

In addition, the only comparative study on the prevention of relapse was conducted to prove that lurasidone is not inferior to the appropriate comparator therapy (risperidone) in the prevention of relapse. However, this study objective was not achieved. According to the findings, an added benefit is not proven. It is uncertain both in the acute treatment and in the prevention of relapse whether the effect lurasidone has on the symptoms of schizophrenia is as good as that of the appropriate comparator therapies.

Comment: Latuda for Schizophrenia was approved in the US in 2010 and in the EU in 2014.