Merck & Co. Inc. (MRK) announced Monday that its New Drug Application for an investigational intravenous or 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 or 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 said it also has filed a marketing authorization application for NOXAFIL IV solution with the European Medicines Agency or EMA and plans to seek regulatory approval for the IV formulation in other countries around the world.
The company noted that it currently markets Noxafil Oral Suspension in the U.S. 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.
In April, the company 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.
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