A drug that fights the fungal infection aspergillosis, which can be life threatening in organ and bone marrow transplant recipients, has been approved by the Antiviral Advisory Committee of the Food and Drug Administration, according to the drug's manufacturer, Merck & Co.
Although the decision is not binding on the FDA, the FDA usually follows the committee's lead.
The committee unanimously recommended approval of intravenous Cancidas (caspofungin acetate) for the treatment of invasive aspergillosis in patients who did not respond to or were intolerant of other antifungal therapies. In addition to transplant recipients, aspergillosis can be life threatening in patients with cancer and the human immunodeficiency virus and AIDS.
Merck presented the FDA with safety and tolerability data from more than 600 people who received Cancidas, including healthy volunteers and patients in clinical studies with invasive aspergillosis, oropharyngeal candidiasis, or oropharyngeal candidiasis. The company also presented data from a clinical study with 69 patients with documented invasive aspergillosis.
Merck said it is not seeking regulatory approval for Cancidas for the treatment of candidiasis.
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