Genentech, Inc. (1 DNA Way, South San Francisco, CA 94080; Tel: 650/225-1000, Fax: 650/225-8326; Website: www.gene.com) has submitted for review to the U.S. Food and Drug Administration (FDA) a Supplemental Biologic License Application (sBLA) for Alteplase (recombinant) for use in restoring function to central venous access devices (CVADs) that have become occluded or blocked, preventing the withdrawal or infusion of vital fluids to medically ill patients. This submission includes data from two pivotal clinical trials (The COOL Trials - Cardiovascular Thrombolytic to Open Occluded Lines) that evaluated the efficacy and safety of Alteplase in restoring flow in occluded catheters in patients with CVADs.
CVADs are long-term, indwelling catheters that are surgically inserted into large veins, such as the jugular, femoral, or subclavian artery of patients with chronic illnesses who require frequent blood tests or receive intravenous infusions. No pharmacological agents approved by the FDA for use in catheter clearance are currently available.
Alteplase is a bio-engineered form of human tissue plasminogen activator, which triggers the body's natural clot-dissolving mechanism.
"Genentech plans to work closely with the FDA through the approval process to make this drug available for this significant unmet medical need," says Arthur D. Levinson, chairman and CEO.
In the United States, it is estimated that more than 5 million catheters are placed each year. Catheter occlusions are a frequent complication associated with CVADs. Up to 60% of all occlusions are caused by the formation of a blood clot.
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