Sucampo Pharma Europe, a wholly-owned subsidiary of Sucampo Pharmaceuticals has reported the withdrawal of its European marketing authorisation application (MAA) for lubiprostone, 24mcg. Lubiprostone is indicated for the treatment of Chronic Idiopathic Constipation (CIC).
The company said that its decision to withdraw the MAA was strategic based upon lubiprostone’s projected commercial position in the global market.
However, Sucampo will evaluate its opportunities to obtain an appropriate label in the EU based on the fact that lubiprostone is the only product registered for chronic therapy for CIC and Irritable Bowel Syndrome with Constipation (IBS-C).
Reportedly, Amitiza (lubiprostone) is co-marketed in the US by Sucampo Pharma Americas, and Takeda Pharmaceuticals North America, and is being co-developed in Japan by Sucampo Pharma, and Abbott.