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Sucampo Pharmaceuticals Inc has announced that its wholly-owned European subsidiary, Sucampo Pharma Europe Ltd, received notice that all of the Marketing Authorisation Applications (MAA) for lubiprostone, 24mcg, (Amitiza) for the indication of Chronic Idiopathic Constipation in adults have been received and validated by the individual regulatory agencies in Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain, Sweden and the United Kingdom.
The applications were submitted using the decentralised process with the United Kingdom serving as the reference Member State. With the validation, the agencies will begin their formal review of the applications.
Amitiza, developed by Sucampo Pharmaceuticals, is an established therapy for Chronic Idiopathic Constipation in adults in the United States. Amitiza, 24mcg, received US Food and Drug Administration (FDA) approval in January 2006 and has been available in the United States for Chronic Idiopathic Constipation in adults since April 2006. In April 2008, Amitiza 8mcg was approved by the FDA for Irritable Bowel Syndrome with Constipation in adult women 18 years of age and older. It is the only approved prescription product for this indication in the United States.
“The validation of our applications and initiation of the review process moves us one step closer to achieving our goal of international expansion,” said Ryuji Ueno MD PhD, founder, chairman and chief executive officer of Sucampo Pharmaceuticals.
“We will work closely with these regulatory agencies over the coming months to address their questions during the review and approval process.”
These applications represent the first major marketing authorisation effort for Sucampo Pharmaceuticals outside the United States. Sucampo Pharmaceuticals continues to review marketing opportunities in other parts of the world in order to build upon the current success of Amitiza in the United States.