FDA Fast Track status for Viprinex anti-stroke treatment in development
RICHMOND, CALIF., January 28, 2005 -- Neurobiological Technologies announced that the FDA has granted the investigational drug, Viprinex (ancrod), Fast Track status for its intended use in patients suffering from ischemic stroke. The Fast Track designation provides for expedited regulatory review for new drug candidates demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions.
Viprinex is under development for decreasing disability in patients with acute non-hemorrhagic stroke, treated within six hours of symptoms.
Viprinex was previously studied in approximately 2,000 patients in various clinical studies in the U.S. and Europe. Currently, the only available therapy for ischemic stroke must be administered within the initial three hours, significantly limiting the number of patients that may be treated. It is estimated that less than five percent of stroke patients are suitable for current therapies and less than three percent actually receive treatment. The estimated direct and indirect costs of stroke in the U.S. in 2004 are thought to be $53.6 billion.
Source: Neurobiological Technologies www.ntii.com
Posted: January 2005