Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Japanese pharmaceutical firm Dainippon Sumitomo Pharma (DSP) has received approval from the Australian Therapeutic Goods Administration (TGA) for marketing Latuda (lurasidone hydrochloride), developed for the treatment of schizophrenia in adults.
Subscribe to our email newsletter
Earlier in March 2013, the company had submitted the marketing authorization application (MAA) to the TGA for review of Latuda.
Lurasidone is an atypical antipsychotic agent, developed by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects.
DSP’s US subsidiary Sunovion Pharmaceuticals had launched lurasidone under the brand name ‘Latuda’ in February 2011 in the US and in September 2012 in Canada.
In Europe, DSP’s development partner, Takeda Pharmaceutical had submitted MAA 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.
In August 2013, Takeda Pharma, a wholly owned subsidiary of Takeda, secured the marketing authorization in Switzerland.
Additionally, 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 the company.
The company expects that the launch of Latuda in Australia will provide many patients suffering from schizophrenia with a new valuable treatment option.
Image: Headquarters of Dainippon Sumitomo Pharma located in Osaka, Japan. Photo: courtesy of Kirakirameister