DSP's Schizophrenia Drug Latuda Approved In Australia
Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced that it has received approval from the Australian Therapeutic Goods Administration (“TGA”) for Latuda (lurasidone hydrochloride) for the treatment of adult patients with schizophrenia in the country. The marketing authorization application (MAA) for Latuda was submitted for TGA review in March 2013.
Schizophrenia is a severe and debilitating form of mental illness, which affects about 24 million people worldwide. Schizophrenia is a treatable disorder. Treatment is most effective at early intervention in the disease’s initial stages. According to the World Health Organization, more than 50% of patients with schizophrenia do not receive appropriate medical care.
Lurasidone is an atypical antipsychotic with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors. The drug has antagonist effects in the receptors mentioned. Lurasidone is also a partial agonist at the serotonin 5-HT1A receptor with no appreciable affinity for histamine or muscarinic receptors.
The drug, developed by DSP, is a global strategic product of the DSP Group. DSP U.S. subsidiary Sunovion Pharmaceuticals Inc. launched lurasidone under the brand name “Latuda” in February 2011 in the U.S. and in September 2012 in Canada. DSP’s development partner, Takeda Pharmaceutical Company Limited, filed a MAA for the drug to the European Medicines Agency (EMA) in September 2012 for the treatment of adults with schizophrenia. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for lurasidone in January of this year.
Takeda Pharma AG won marketing authorization for the drug in Switzerland in August 2013. DSP has filed an application with the Taiwan Food and Drug Administration for lurasidone for the treatment of schizophrenia. Phase III clinical trials are currently ongoing in Japan and in China for evaluation of lurasidone.
The company expects the drug’s launch in Australia will provide a new treatment option for many patients afflicted with schizophrenia in the country.