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
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
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.