Merck & Co has been granted its first marketing approval, in the USA,for Cancidas (caspofungin acetate), a new intravenous antifungal drug. The product is the first in a new class of agent, called echinocandins or glucan synthesis inhibitors, and is thought to work by attacking the fungal cell wall. The company said that Cancidas would be launched in the USA at the beginning of February.
Cancidas represents the first new type of antifungal to be registered in the USA for a decade and is indicated for the treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal therapies, including amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Aspergillosis is usually found in individuals who are immune-suppressed, such as those receiving cancer chemotherapy, infected with HIV or organ transplant patients.
The US Food and Drug Administration based its decision on the results of a small, multicenter, open-label study of Cancidas, as well as considering efficacy data submitted in preclinical and supportive clinical studies. An advisory panel to the FDA unanimously recommended earlier this month that the FDA approve Cancidas (Marketletter January 22), although questions were raised about the drug's long-term efficacy, particularly with regard to tissue accumulation. Some of the panel members were concerned about the potential for bias in the non-comparative study, primarily because the company had used historical controls, rather than utilizing a randomized clinical trial design with a placebo group.
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