Monday, Oct 2, 2000
South San Francisco, Calif. -- October 2, 2000 --Genentech, Inc., today announced that it 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) which evaluate the efficacy and safety of Alteplase, recombinant in restoring flow in occluded catheters in patients with CVADs.
"Genentech plans to work closely with the FDA through the approval process to make this drug available for this significant unmet medical need," said Arthur D. Levinson, Ph.D., chairman and chief executive officer. "If approved, we look forward to providing Alteplase to medical professionals who are seeking alternatives to surgical care and improving patient care."
No pharmacological agents approved by the FDA for use in catheter clearance are currently available.
Central venous access devices 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, which may include cancer, diabetes, hemophilia or AIDS.
In the United States, it is estimated that more than five million catheters are placed each year, through which patients receive some form of life-saving medication or critical treatment, such as chemotherapeutic agents, antibiotics or nutritionals. These patients also require frequent withdrawal of blood for testing to accurately monitor their health. Catheter occlusions are a frequent complication associated with CVADs. It is estimated that up to 60 percent of all occlusions are caused by thrombosis, the formation of a blood clot.
Alteplase, recombinant, is a bio-engineered version of the naturally occurring tissue plasminogen activator (t-PA), which works to dissolve blood clots by triggering the body's own clot-dissolving mechanism.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
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