FDA approves Astellas’ Mycamine for injection

Article updated: 6/24/2013 1:23 PM

The U.S. Food and Drug Administration as approved a supplemental new drug application for the use of Northbrook-based Astellas Pharma U.S. drug Mycamine for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants.

"We are pleased with FDA's approval of Mycamine for use in pediatric patients four months and older," said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma, Inc. "This expanded indication supports the safety and efficacy of Mycamine and delivers on our mission to provide treatments that can help to improve patient care."

Candida, a yeast that causes common fungal infections, is the third most common cause of pediatric health care associated bloodstream infection. Mycamine inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida, the company said in a release.

The overall safety of Mycamine was assessed in 479 patients, ages three days through 16 years, who received at least one dose of Mycamine in 11 separate clinical trials.

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FDA approves Astellas’ Mycamine for injection