FDA Approves Merck's Noxafil Injection For Aspergillus And Candida Infections
By Cyndi Root
Merck announced in a press release that the Food and Drug Administration (FDA) has approved a Noxafil injection for intravenous (IV) use. The antifungal agent is indicated for the prevention of Aspergillus and Candida infections. The approval allows Merck to market the IV formulation along with its already approved tablet and oral suspension. Dr. Nicholas Kartsonis, executive director or Infectious Disease at Merck Research Laboratories, 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.”
Aspergillus and Candida
The Aspergillus and Candida fungal species are common pathogens and responsible for many infections. Immunocompromised people such as hematopoietic stem cell transplant (HSCT) recipients and those undergoing chemotherapy for hematologic malignancies are more at risk from these invasive fungal attackers. Diagnosing the fungus is often delayed and the infection is difficult to treat. New agents are needed that are less toxic and more effective.
Noxafil
Noxafil (posaconazole) is a drug to prevent these serious infections. It comes in a 100 mg delayed-release tablet and a 40 mg/mL oral suspension. The Noxafil injection is for adults over the age of 18 years of age, while the other formulations are for patients as young as 13 years old. On the first day of Noxafil injection therapy, the patient takes two doses (one 300 mg vial/dose). On following days, the patient takes a dose (one 300 mg vial) once a day for maintenance. The injection is administered over 90 minutes through a central venous line. Merck plans to make the injection available in mid April.
Clinical Trials
Merck conducted clinical trials for the Noxafil injection. 268 people enrolled in the Posaconazole Injection Study 1. Patients were predominately white with an average age of 51 years of age. Half were men and half were women. Patients had targeted conditions such as graft-versus-host disease (GVHD) or HSCT recipients. Patients reported adverse reactions similar to the oral suspension of Noxafil. Reactions included nausea, fever, diarrhea, and hypokalemia. Less than five percent of patients experienced other reactions such as blood and lymphatic system disorders, endocrine disorders, and nervous system disorders.