FDA approves Schering-Plough’s anti-fungal drug

Invasive fungal infections most often occur in people who are immunocompromised or immunosuppressed, and are increasingly caused by moulds such as Aspergillus. Patients undergoing stem cell transplant or chemotherapy who develop the infections have a high mortality rate of 60-90%.

The approval is based on results of two head-to-head randomized clinical studies, the largest prophylaxis studies conducted to date in these high-risk patient populations. A total of more than 1,200 patients were enrolled in these studies, which demonstrated substantially fewer breakthrough Aspergillus infections in these patients. In high-risk neutropenic patients, prophylaxis with Noxafil was associated with decreased all-cause mortality versus the comparator drugs.

“Noxafil can help prevent patients from developing life-threatening invasive fungal infections while being treated for serious conditions, such as acute leukemia or graft-versus-host disease,” said John Perfect, director at Duke University mycology research unit.