Merck & Co says that a New Drug Application for a tablet formulation of the company's antifungal Noxafil has been accepted for review by the US Food and Drug Administration.
Merck currently markets Noxafil (posaconazole) in liquid form for invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being "severely immunocompromised". This covers patients who have received haematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts as a result of chemotherapy.
Specifically, Merck is seeking FDA approval of Noxafil tablets for once-daily administration, following a twice-a-day loading dose on the first day of therapy. The pill has already been filed with the European Medicines Agency and the drug giant plans to seek regulatory approval for the tablet formulation in other countries around the world.
Robin Isaacs, head of infectious disease clinical research at Merck Research Laboratories, said the filing for a Noxafil pill "is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting". He added that "invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients".