Large data set supports safety of Mycamine in at risk patients

30 September 2007

New data from a pooled analysis of 17 clinical studies demonstrate that Mycamine (micafungin sodium) for injection offers a favorable clinical safety profile in hospitalized patients of all ages with serious, underlying diseases with immunosuppressed status, according to the agent's originator, Japanese drug major Astellas.

These studies, which represent the largest published safety data for an antifungal medicine to date, looked at more than 3,000 patients who received at least one dose of Mycamine, with median treatment lasting 18 days. Importantly, the investigators attribute few adverse events to treatments, even in longer periods of exposure. The comparative study data, which were presented at the 47th annual Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Chicago, USA, showed that the agent had a similar safety profile to fluconazole, caspofungin and liposomal amphotericin B.

Mycamine is approved for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections and in patients undergoing hematopoietic stem cell transplantation, Astellas noted.

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