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Volume 2 Published - 14:00 UTC    08:00 EST    11-January-2001      
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Back To Vidyya FDA Panel Recommends Approval Of Cancidas®

An Investigational Antifungal Drug

The Antiviral Advisory Committee of the U.S. Food and Drug Administration today unanimously recommended approval of Cancidas® (caspofungin acetate), an investigational intravenous antifungal medicine, for the treatment of invasive aspergillosis in patients who did not respond to or were intolerant of other antifungal therapies.

Merck presented safety and tolerability data from more than 600 individuals who received Cancidas in clinical studies in patients with invasive aspergillosis, oropharyngeal and/or esophageal candidiasis and in healthy volunteers, and efficacy data from a clinical study with 69 patients with documented invasive aspergillosis. At present, Merck is not seeking regulatory approval for the treatment of candidiasis.

Cancidas is an investigational antifungal drug known as an echinocandin. It inhibits the synthesis of Beta (1,3)-D-glucan, an integral component of the fungal cell wall that is not found in human cells.

Aspergillosis is a life-threatening fungal infection in high-risk patient populations, especially cancer patients, organ and bone marrow transplant recipients, and patients with HIV/AIDS. Invasive aspergillosis is an increasingly prevalent disease in immunocompromised patients with very high mortality rates.

Cancidas was discovered in Merck's research laboratories in Madrid, Spain. Merck submitted a New Drug Application for Cancidas to the FDA on July 28, 2000, and received fast-track review. The recommendations of the advisory committee are not binding on the FDA.

Advisory committee recommendation could mean an approval soon. Watch Vidyya for the complete prescribing information for Cancidas.

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Editor: Susan K. Boyer, RN
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