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news.The FDA office of orphan product development has granted orphan drug status to Anthera Pharmaceuticals's A-001 for the prevention of acute chest syndrome in patients with sickle cell disease.
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A-001 is currently being evaluated for acute chest syndrome in a Phase II clinical trial in the US called IMPACTS (investigation of the modulation of phospholipase in acute chest syndrome). In addition to orphan drug designation, the FDA has granted Anthera expanded enrollment of the IMPACTS trial to patients as young as five years of age.
James Pennington, executive vice president and chief medical officer of Anthera, said: “The orphan drug designation signifies an important milestone for Anthera in the development of A-001. Orphan drug designation, in addition to our recent fast track designation from the FDA, further strengthens our development program and allows us to accelerate our efforts to develop a new treatment for this devastating condition, for which there is no cure.”