Merck’s Noxafil IV Gets Priority Review

Merck has received Priority Review status from the FDA for its NDA of an IV solution formulation of antifungal agent, Noxafil. The company has filed an MAA for Noxafil IV solution with the EMA and plans to seek regulatory approval for the IV formulation in other countries around the world.

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.

Merck 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, 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.