13 Aug 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Japanese companies Dainippon Sumitomo Pharma and Takeda Pharmaceutical have obtained approval for marketing authorization by Swissmedic for atypical antipsychotic medication lurasidone hydrochloride for treatment of patients with schizophrenia.
Lurasidone, orally administrated once daily, is an atypical antipsychotic medication discovered and developed by DSP. In the US, it was approved for the treatment of schizophrenia and also for major depressive episodes associated with bipolar I disorder in October 2010 and June 2013, respectively. It is being marketed as Latuda in the US and Canada by Sunovion Pharmaceuticals, a wholly owned subsidiary of DSP.
In March 2011, DSP and Takeda signed a license agreement for lurasidone for the joint development and exclusive commercialization by Takeda in the 26 member states of the European Union at that time excluding the United Kingdom, Switzerland, Norway, Turkey and Russia.
The marketing authorization application was submitted in Switzerland in March 2012 based on the dossier used for submissions and subsequent approvals by the US FDA and Health Canada. In the European Union, the marketing authorization application was accepted for review by the European Medicines Agency in October 2012 and is currently under review.