FDA Approves Expanded Use of Caspofungin Acetate for Paediatric Patients

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FDA Approves Expanded Use of Caspofungin Acetate for Paediatric

Patients

DG News*

http://www.docguide.com/news/content.nsf/news/852571020057CCF68525749

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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.