European Marketing Authorisation for Latuda® now held by Sunovion Pharmaceuticals Europe Ltd.

The licence for the joint development and exclusive commercialisation of all pharmaceutical products containing lurasidone (LATUDA®), an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults of 18 years and over, has been transferred back to Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo Dainippon Pharma") effective 31 January 2016.

As of 15 February 2016, in the EU and EEA the Marketing Authorisation Holder is Sunovion Pharmaceuticals Europe Ltd. (Sunovion), a wholly owned subsidiary of Sunovion Pharmaceuticals Inc., an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma.

Latuda®
LATUDA® (lurasidone) is an atypical antipsychotic developed originally by Sumitomo Dainippon Pharma, characterized by a unique chemical structure and an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. Information about ongoing and completed clinical trials can be found here.

 

Latuda® availability in Europe

Sunovion is working to ensure continuity of supply of LATUDA during the transition period. Below are the details for the countries in Europe where Latuda® is currently commercialised:

Norway/Denmark/Finland/Netherlands: From 16 May 2016 Sunovion will be solely responsible for distributing LATUDA and will communicate any changes in advance. There will be a transition period to Sunovion packaging and supply to ensure the availability of LATUDA is maintained.

United Kingdom: No change - LATUDA will continue to be distributed by Sunovion.

Switzerland: Sunovion’s partner company, Medius AG, is the Marketing Authorisation Holder in accordance with Swiss law. Following May 1st there will be a period of transition to Medius AG packaging and supply of LATUDA will be maintained.