Mar. 25, 2014Products
Dainippon Sumitomo Pharma Announces the Marketing Authorization in Australia for Atypical Antipsychotic Agent Latuda
Osaka, Japan, March 25, 2014 - Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Headquarters: Osaka, Japan; President: Masayo Tada) announces that the Australian Therapeutic Goods Administration ("TGA") granted the marketing authorization for Latuda® (lurasidone hydrochloride) for the treatment of adults with schizophrenia on March 19, 2014 (Australia time).
The marketing authorization application was submitted in March 2013 for review by TGA.
Lurasidone is a global strategic product of the DSP Group. Sunovion Pharmaceuticals Inc., a U.S. subsidiary of DSP, launched lurasidone under the brand name "Latuda®" in February 2011 in the U.S., and in September 2012 in Canada. In Europe, Takeda Pharmaceutical Company Limited, DSP's development partner, submitted a marketing authorization application for lurasidone to the European Medicines Agency ("EMA") in September 2012 for the treatment of adults with schizophrenia, and EMA's Committee for Medicinal Products for Human Use ("CHMP") issued a Positive Opinion in January 2014. Takeda Pharma AG, a wholly owned subsidiary of Takeda, obtained the marketing authorization in Switzerland in August 2013. An application has been filed with the Taiwan Food and Drug Administration for schizophrenia, and Phase III clinical trials are underway in Japan and in China by DSP.
DSP hopes that the launch of LATUDA in Australia will provide many patients suffering from schizophrenia with a new valuable treatment option.
Lurasidone is an atypical antipsychotic, developed originally by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors.