Japan-based Sumitomo Dainippon Pharma has published positive results from the phase III JEWEL trial into its drug Latuda (lurasidone hydrochloride) for patients with schizophrenia.
The JEWEL study compared a 40mg dose per day of Latuda to placebo. There were 245 participants in the Latuda group, compared to 233 in the placebo arm.
The drug reached its primary endpoint of statistically significant improvement from baseline of Positive and Negative Syndrome Scale (PANSS) after six weeks of treatment compared to placebo.
It also met its secondary endpoint in terms of change from baseline on the Clinical Global Impressions-Severity of Illness Scale following six weeks of treatment compared to placebo.
The drug was well tolerated by the trial participants and adverse events were mild and consistent with prior studies; 47% of those in the Latuda group experienced adverse events, compared to 51% in the placebo group. Fewer participants taking the drug discontinued treatment than those taking the placebo.
Due to the success of this schizophrenia trial, Sumitomo Dainippon intends to file a new drug application (NDA) for Latuda by the Japanese authorities by the end of the 2019 financial year (FY 2019). It also plans to submit an approval application in China.
Latuda was approved for patients with schizophrenia in the US in 2010, Canada in 2012 and the European Union in 2014, as well as other markets, such as Brazil and Australia. In the US, the drug is marketed by Sunovion Pharmaceuticals.
Earlier this week the US Food and Drug Administration approved a generic version of Latuda marketed by Lupin, a US-based company linked with an Indian corporation. IQVIA has estimated that the drug is worth $3.2bn in the US market.
Sumitomo Dainippon also plans to submit an NDA for the drug for bipolar depression in Japan in FY 2019 based on a phase II study completed in June 2017. Latuda is approved in the US, Canada, Russia, Brazil and Taiwan for bipolar disorder currently.