FDA Accepts Merck’s NDA for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole)
Merck has announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL ® (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA).
Merck currently markets NOXAFIL Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic 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 (neutropenia) as a result of chemotherapy.
“Invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients,” said Robin Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “This filing for a tablet formulation of NOXAFIL is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting.”
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 company has filed a marketing authorization application for NOXAFIL tablets with the European Medicines Agency (EMA) and plans to seek regulatory approval for the tablet formulation in other countries around the world.