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The U.S. Food and Drug Administration has approved Astella Pharma Inc's Supplemental New Drug Application (sNDA) for use of Mycamine in the treatment of patients with Candidemia, Acute Disseminate Candidiasis, Candida Peritonitis and Abscesses.

Mycamine, an injectable treatment, is part of the echinocandins class of antifungal agents and was approved for use in 2005 for patients with esophageal candidiasis. It is the only approved treatment for the prophylaxis of Candida infections in patients that are undergoing hematopoietic stem cell transplantation.

"The FDA's approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Executive Officer, Astellas Pharma US, Inc. "The approval of this additional indication is another step toward fulfilling our mission to provide innovative treatments such as MYCAMINE to help patients with significant medical needs."

Candidemia is a fungal infection that happens when the Candida species enters the blood which causes a bloodstream infection that has the potential to spread to other parts of the body. The U.S. Center for Disease Control states that Candidemia is the fourth most common bloodstream infection in the U.S.

[Source: PRNewsWire]