Acute peripheral arterial occlusion (PAO), is the blocking of arterial blood flow to a lower limb by a blood clot. Affecting more than 100,000 people in the US each year, with similar incidence in Europe, acute PAO is the result of underlying peripheral arterial disease, in which chronic fatty plaque buildup restricts blood flow and is then complicated by the formation of an acute clot.
The designation confers several benefits, including protocol development assistance and a 10-year period of market exclusivity following market authorization. Nuvelo has already obtained orphan drug designation from the FDA for the drug in this indication.
“The EMEA’s decision to grant alfimeprase orphan drug designation reinforces our belief that alfimeprase has the potential to become an important treatment option worldwide for patients with acute PAO,” said Dr Michael Levy, senior vice president of R&D for Nuvelo.