Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous (IV) solution formulation of the company's antifungal agent, NOXAFIL
(posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration (FDA).
Priority review designation is assigned to applications for drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
The company also has filed a marketing authorization application for NOXAFIL IV solution with the European Medicines Agency (EMA) and plans to seek regulatory approval for the IV formulation in other countries around the world.
Merck currently markets NOXAFIL Oral Suspension in the U.S. for prophylaxis of invasive
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.
In April, Merck announced that it had filed new drug applications for an investigational, tablet formulation of NOXAFIL with both the FDA and EMA. These applications are currently under review.
Selected safety information about NOXAFIL Oral Suspension
NOXAFIL is contraindicated in persons with known hypersensitivity to posaconazole, any component of NOXAFIL, or other azole antifungal agents.
NOXAFIL (posaconazole) is contraindicated with sirolimus. Concomitant administration of NOXAFIL with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
NOXAFIL is contraindicated with CYP3A4 substrates that prolong the QT interval. Concomitant administration of NOXAFIL with the CYP3A4 substrates pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and rare occurrences of torsades de pointes.