Nuvelo Gets FDA Fast Track Status For Alfimeprase>NUVO
SAN CARLOS (Dow Jones)--Nuvelo Inc. (NUVO) received fast-track designation from the Food and Drug Administration for its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion, or "leg attack."
In a press release Monday, the company said alfimeprase is in Phase 3 clinical trials for the treatment of acute peripheral arterial occlusion and catheter occlusion.
Nuvelo said alfimeprase may also be able to treat strokes, deep venous thrombosis and myocardial infarction.
Acute peripheral arterial occlusion happens when arterial blood flow to a lower limb is blocked by a clot.
Alfimeprase is an enzyme produced by recombinant DNA technology that rapidly resolves blood clots by directly degrading a protein that provides scaffolding for the clots.
Fast-track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and which are intended for the treatment of a serious or life-threatening condition.
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