Merck Sharp and Dohme’s Noxafil receives FDA approval for IV use

Merck Sharp and Dohme (MSD) has received approval from the US Food and Drug Administration (FDA) for a new formulation of its Noxafil drug for intravenous use.

The antifungal agent is already marketed in a 40 mg/mL oral format and in 100 mg delayed-release tablets, and all three forms of the drug have been indicated for prophylaxis of the invasive aspergillus and candida infections. 

Patients with a severely compromised immune system are at high risk of these infections, particular those who have received hematopoietic stem cell transplants and are experiencing graft-versus-host disease, or those with hematologic malignancies and prolonged neutropia resulting from chemotherapy.

Under the FDA approval, the Noxafil injection is indicated for use in patients aged 18 or older, while the tablets and oral solution can be used by those 13 years of age or older.

Nicholas Kartsonis, MSD's executive director of infectious disease, said: "The availability of a Noxafil formulation for intravenous administration is particularly important for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation."