Sumitomo Dainippon Pharma Announces Approval of Atypical Antipsychotic Agent, LATUDA Tablets in Japan

Ref: Sumitomo Dainippon
Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced today that a new drug application for LATUDA® Tablets (generic name: lurasidone hydrochloride, hereinafter, “this Drug”), an atypical antipsychotic agent for schizophrenia and bipolar depression, was approved in Japan on March 25. Sumitomo Dainippon Pharma will launch this Drug after NHI drug price listing.
Sumitomo Dainippon Pharma submitted a new drug application for approval of manufacturing and marketing for LATUDA® Tablets on July 31, 2019, based mainly on the results of multinational phase 3 studies (PASTEL study and JEWEL study) and a long-term extension study (JEWEL extension study) in schizophrenia patients and those of a multinational phase 3 study (ELEVATE study) in bipolar I depression patients. As this Drug was prior assessment consultation item evaluated before approval application based on the data planned for submission, its new drug application was approved after a review period of around 8 months, which is shorter than usual.
This Drug is an atypical antipsychotic agent with an original chemical structure created by Sumitomo Dainippon Pharma that has antagonist effects for dopamine D2, serotonin 5-HT2A, and serotonin 5-HT7 receptors. It is also a partial agonist for serotonin 5-HT1A receptors but has no appreciable affinity for histamine H1 or muscarinic M1 receptors.
Since this Drug was approved in the U.S. in October 2010 for schizophrenia in adults, it has been approved for this indication in 47 countries and regions including the U.S. and European countries. It has also been approved in a total of 7 countries and regions, including the U.S., for depressive episode associated with bipolar I disorder. In foreign guidelines, it is considered to be an antipsychotic with low risk of weight gain, and is recommended as one of first-choice drugs for bipolar depression where there are few therapy options.
By providing a new treatment option with this approval, Sumitomo Dainippon Pharma aims to make a contribution to the treatment of schizophrenia and bipolar depression in Japan.