The application has been filed using the decentralized procedure with the Medicines and Healthcare Products Regulatory Agency of the UK serving as the reference member state with additional applications to be filed with the member states of Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain and Sweden. Other than the US and Canada, Sucampo Pharmaceuticals retains all commercial rights for Amitiza for Europe and the rest of the world.
Ryuji Ueno, chairman and CEO of Sucampo Pharmaceuticals, said: “Sucampo is expanding to Europe. Our filing in the UK represents a major event in our plans for international expansion. We see great opportunities because Amitiza is claimed to be the only approved US prescription drug for the treatment of chronic idiopathic constipation in adults. It also claimed that,in Europe, there are no approved drugs for this indication.”