The company’s lead product candidate, alfimeprase, has received the designation for the treatment of acute peripheral arterial occlusion (PAO), or “leg attack.” Acute PAO occurs when arterial blood flow to a lower limb is blocked by a clot.
Fast track designation can potentially facilitate development and expedited review of biologics license applications (BLA). Fast track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.
Alfimeprase is currently being studied in phase III clinical trials for the potential treatment of acute PAO and catheter occlusion, and may have utility in a wide range of additional thrombotic-related conditions such as stroke, deep venous thrombosis and myocardial infarction. According to Nuvelo, collectively these disorders are among the most common causes of death and morbidity in the Western world.
“We recently received a special protocol assessment agreement for NAPA-3, our second pivotal phase III trial in acute PAO. Fast track designation represents a further step in the achievement of our regulatory strategy for alfimeprase,” said Dr Ted Love, chairman and CEO of Nuvelo.
Nuvelo is to partner German firm Bayer AG in the marketing and develop the drug.