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FDA Approves Expanded Use of Caspofungin Acetate for Paediatric Patients
NEW YORK -- August 6, 2008 -- The US Food and Drug Administration (FDA) has approved an expanded label for caspofungin acetate (CANCIDAS), as echinocandin therapy for the treatment of paediatric patients aged 3 months to 17 years with indicated fungal infections.
"In the paediatric population, safety and tolerability can be especially critical," said lead investigator Theoklis Zaoutis, MD, Division of Infectious Diseases, Children's Hospital, Philadelphia, Pennsylvania.
"With the expanded label for caspofungin acetate that now includes use in paediatric patients aged 3 months to 17 years, clinicians have a new option … for treating these paediatric patients with indicated fungal infections."
The expanded label for caspofungin acetate is based on data from 5 prospective clinical studies involving 171 paediatric patients. Two clinical trials demonstrated the safety, efficacy, and tolerability profile of caspofungin acetate comparable to that of adults.
The efficacy and safety of caspofungin acetate has not been adequately studied in prospective clinical trials involving neonates and infants aged less than 3 months.
The most common adverse reactions in paediatric patients were pyrexia (29.2%), decreased blood potassium (15.2%), diarrhoea (14.0%), increased aspartate aminotransferase (11.7%), rash (11.7%), increased alanine aminotransferase (11.1%), hypotension (11.1%), and chills (11.1%).
SOURCE: Merck & Co., Inc.
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