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New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
Date:9/18/2007

s has a history of commitment to the development of medicines that can change the way healthcare providers treat infectious disease," said Nkechi Azie, MD, Medical Director, Medical Sciences, Astellas. "We are proud to see this number of micafungin studies at ICAAC and will continue to work collectively in the anti-infective community toward optimal treatment options for these patients."

Susceptibility Testing of Breakpoints with MYCAMINE

Results from multiple studies were presented at ICAAC, illustrating the benefits of MYCAMINE in various populations and its activity as an antifungal agent. Of the presented abstracts, the following is noteworthy as the first proposing susceptibility breakpoints of echinocandins, specifically MYCAMINE:

A Proposal for an Antifungal Susceptibility Testing (AST) Breakpoint of Micafungin and Candida: Integration of AST Surveys and Correlation with Clinical Outcomes

In this study, investigators looked at two large, well-known medical databases to determine if candida isolates are more likely to be susceptible or resistant when exposed to MYCAMINE. The survey included more than 400 patients and 5700 isolates. The analysis found candida isolates are more likely to be susceptible to MYCAMINE.

About the Safety Analysis

This pooled analysis included data from 17 clinical trials of MYCAMINE conducted between 1998 and 2006, and looked at 3,028 patients from all age groups with severe and life-threatening underlying conditions, with approximately half of patients undergoing transplants or being treated for cancer. Patients in clinical studies with MYCAMINE have complex underlying conditions, such as cancer, HIV and hematopoetic stem cell transplantation and complications such as bacterial sepsis. Data are from 17 clinical studies in patients who received at least a single dose of MYCAMINE.

Across all age groups, few adverse events were considered by the investigators to be treatment related, and no adve
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SOURCE Astellas Pharma US, Inc.
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