GW Pharmaceuticals has filed its cannabis-based medicine, Sativex, for regulatory approval in four European countries, including the UK.
The filing, for the symptomatic relief of spasticity in patients with multiple sclerosis (MS), is the UK company's second attempt to get its flagship product on the market. It has been made under the 'decentralised procedure' in the UK, Spain, Denmark and the Netherlands.
Under this system, the UK will act as a reference member state, which will consult with the other three countries. If the drug it approved, it will be approved simultaneously in all four countries and marketed in the UK by Bayer Heathcare and in the rest of Europe by Spanish firm, Almirall.
GW tried to get Sativex approved last year, but was knocked back when it lost an appeal against a regulatory decision requiring it to conduct further clinical trials.
Source: PM Live
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