FDA approves Noxafil DR for Fungal Infections- Merck

The FDA has approved Noxafil (posaconazole) delayed-release tablets, from Merck. This new formulation with a loading dose of 300 mg is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Approval is based on a multicenter study that evaluated the pharmacokinetic properties, safety and tolerability of Noxafil DR in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who had developed or were anticipated to develop significant neutropenia, and in patients who had undergone HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD. The most frequently reported adverse reactions (>25%) were diarrhea, fever and nausea.