GW Pharmaceuticals plc (GWP:AIM) today announces that it has filed a regulatory submission for Sativex for the treatment of spasticity due to Multiple Sclerosis. This submission follows the recent announcement of a positive Phase III trial in this indication.
The regulatory submission has been filed in the UK and Spain under the European decentralised procedure. The UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State and has validated the application.
It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010.
Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.
Sativex will be marketed in the UK by Bayer HealthCare, and in the rest of the European Union by Laboratorios Almirall S.A.
Dr Stephen Wright, GW’s R&D Director, said, “We are pleased to have completed and filed the regulatory submission within a very short period of time of receiving the latest positive Phase III data. We look forward to working with the regulatory authorities in their review of the application.”