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The European marketing authorisation application (MAA) for lubiprostone, 24mcg, which is used to treat Chronic Idiopathic Constipation (CIC) has been withdrawn by Sucampo Pharma Europe.
The group, owned by Sucampo Pharmaceuticals, said the decision was based on lubiprostone’s projected commercial position in the global market.
Lubiprostone is the only product registered for chronic therapy for CIC and Irritable Bowel Syndrome with Constipation (IBS-C) and Sucampo may look to obtain an appropriate label in the EU on this basis.
Amitiza (lubiprostone) is reportedly being co-market in the US by Sucampo Pharma Americas, with Takeda Pharmaceuticals North America. It is being co-developed in Japan by Abbott and Sucampo Pharma.
Copyright Press Association 2009