Aspireo Receives Positive Opinion from EMA for Orphan Disease Designation for Somatoprim
News Nov 26, 2012
Aspireo Pharmaceuticals Limited has announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on an application for orphan medicinal product status for Aspireo’s Somatoprim (DG3173) for the treatment of acromegaly.
The positive opinion and recommendation has been forwarded to the European Commission for approval.
The designation would grant Aspireo ten years of marketing exclusivity in the European Union upon obtaining market authorization as an orphan medicinal product. In addition, Aspireo would benefit from reduced regulatory fees.
“EMA’s decision to recommend Somatoprim for orphan medicinal product status is an important milestone in the development of this drug”, said Carsten Dehning, CEO of Aspireo.
Dehning continued, “By this resolution, EMA recognizes the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it. The ongoing clinical phase 1b and phase 2a studies are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients.”
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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