EU approval for Dainippon Sumitomo and Takeda’s Latuda

28 March 2014

Japanese drug majors Dainippon Sumitomo Pharma (TYO: 4506) and Takeda Pharmaceutical (TYP: 4502) have received European Commission approval for once-daily oral Latuda (lurasidone) for the treatment of schizophrenia in adults.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for Latuda earlier this year (The Pharma Letter January 24, 2014).

Latuda will be marketed in the UK by Sunovion Pharmaceuticals Europe, a subsidiary of DSP, and across Europe by Takeda subsidiaries. Takeda licensed exclusive commercialization rights to lurasidone for 26 member states of the European, excluding the UK and Norway, as well as Switzerland, Turkey and Russia (The Pharma Letter April 1, 2011). Sunovion gained US Food and Drug Administration for the drug in 2010 (TPL October 29, 2010).

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