Nuvelo receives FDA fast track status for alfimeprase

By Angela McDaniels

Seattle, Jan. 23 - Nuvelo Inc. said it has been granted a fast track designation by the Food and Drug Administration for lead product candidate alfimeprase, which is being developed for the treatment of acute peripheral arterial occlusion or "leg attack."

Fast track designation indicates that the FDA will assist the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

Alfimeprase is being studied in phase 3 clinical trials for the potential treatment of acute peripheral arterial occlusion 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, the company said.

Acute peripheral arterial occlusion occurs when arterial blood flow to a lower limb is blocked by a clot. Nuvelo said that if blood flow is not restored, leg attack can lead to permanent nerve and muscle damage, gangrene and in the most severe cases, amputation and death.

Currently, because there are no FDA-approved thrombolytic therapies available to treat acute peripheral arterial occlusion, off-label use of plasminogen activators often occurs, the company said. Plasminogen activators may require a prolonged infusion of 24 to 36 hours, carry the risk of significant bleeding complications and typically require admission to the intensive care unit for the duration of the infusion.

Nuvelo said alfimeprase is an enzyme produced by recombinant DNA technology that rapidly resolves blood clots through a unique mechanism of action: it directly degrades fibrin, a protein that provides the scaffolding for blood clots. In clinical studies to date, alfimeprase has been shown to resolve peripheral arterial clots within four hours of initiation of dosing and to clear occluded catheters in 15 minutes or less.

Nuvelo is a San Carlos, Calif., pharmaceutical company that develops and commercializes novel drugs for acute cardiovascular and cancer therapy.

Nuvelo has licensed the commercialization of alfimeprase outside the United States to Bayer HealthCare, a subsidiary of Bayer AG.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.