Sumitomo Dainippon finally files for Japanese approval of lurasidone

31 July 2019

Sumitomo Dainippon Pharma (TYO: 4506) has at last submitted a new drug application for approval of manufacturing and marketing for lurasidone hydrochloride in Japan for the treatment of schizophrenia and bipolar depression, with the news pushing the Japanese pharma major’s shares up 3.24% to 2,007 yen today.

Lurasidone is an atypical antipsychotic agent that is believed to have 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.

Lurasidone is a core product of Sumitomo Dainippon group, sold by subsidiary Sunovion Pharmaceutical under the product name Latuda in the USA and other countries, with revenue of 184.5 billion yen ($1.7 billion) posted in North America in fiscal year 2018.

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