FDA Extends Review Deadline for Astellas’ Anti-Fungal Agent

The FDA extended the action date for its review of Astellas’ injectable antifungal drug Mycamine for the treatment of candidemia and other Candida infections, or invasive fungal infections, the company announced Sept. 3.

Mycamine (micafungin sodium) is approved for the treatment of patients with esophageal candidiasis and as a preventive medication for Candida infections in patients undergoing hematopoietic stem cell transplantation.

Astellas said the agency’s request was not for new information, just a reanalysis of existing safety and efficacy data already submitted in the supplemental new drug application (sNDA).

The application originally was filed in December 2006 and now has a late January 2008 action date, the company said. If approved, the sNDA would expand the product’s indication to all forms of Candida fungal infections, Astellas said.