FDA fast tracks Nuvelo's blood clot drug alfimeprase
California-based Nuvelo has been granted fast track designation by the US Food and Drug Administration (FDA) for alfimeprase, used in the treatment of acute peripheral arterial occlusion (PAO), or 'leg attack'.
California-based Nuvelo has been granted fast track designation by the US Food and Drug Administration (FDA) for alfimeprase, used in the treatment of acute peripheral arterial occlusion (PAO), or 'leg attack'.
Alfimeprase is currently being studied in Phase III clinical trials for the potential treatment of acute PAO and catheter occlusion (CO), and may help a range of other thrombotic-related conditions such as stroke, deep venous thrombosis and myocardial infarction. Ted Love, chairman and ceo of Nuvelo said: 'With a more defined regulatory path, a Phase III program continuing to progress and a strong global commercialisation partner in Bayer HealthCare, we believe we are progressing toward our goal of bringing this therapy to individuals suffering from clot related disorders.'
Alfimeprase is being studied in an ongoing Phase III trial, for the treatment of acute PAO. The first trial is expected to complete enrollment in the second half of 2006 and the second trial will begin enrollment in early 2006. The drug is also being studied in a Phase III clinical programme for the treatment of CO.
Acute PAO occurs when arterial blood flow to a lower limb is blocked by a clot and it affects more than 100,000 people in the US each year. Currently, because there are no FDA-approved thrombolytic therapies available to treat acute PAO, off-label use of plasminogen activators often occurs. However, plasminogen activators may require a prolonged infusion averaging 24 to 36 hours in patients and carry the risk of significant bleeding complications. Alfimeprase is an enzyme produced by recombinant DNA technology that rapidly resolves blood clots by degrading fibrin, a protein that provides the scaffolding for blood clots.