Genentech files sBLA for Activase catheter clearance
Genentech has filed a supplemental Biologics License Application withthe US Food and Drug Administration seeking expanded labeling for Activase (alteplase), for use in restoring function to blocked central venous access devices, which prevents the administration or withdrawal of fluids to patients. The dossier comprises data from two clinical trials, says the company, adding that there are no pharmacological agents currently approved by the FDA for use in catheter clearance. About 5 million catheters are placed every year in the USA and occlusions are frequent, with up to 60% caused by the formation of a blood clot.
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