Noxafil Receives New Indication for Potentially Fatal Mold Infection

Noxafil Receives New Indication for Potentially Fatal Mold Infection

July 1, 2021 – The U.S. FDA has approved a new indication for Noxafil^® (posaconazole – Merck) intravenous (IV) injection and delayed-release oral tablets to treat invasive aspergillosis in patients who are at least 13 years old. The drug first received FDA approval in 2006 and is also indicated to prevent Aspergillus and Candida infections in certain individuals, as well as to treat oropharyngeal candidiasis (Noxafil oral solution only) in pediatric patients ages 13 years and up.

Invasive aspergillosis is caused when normally harmless Aspergillus mold infects an immunocompromised individual. The infection spreads rapidly, often beginning in the lungs and then traveling to organs such as the brain, heart, kidneys, and skin. The disease can be fatal, with symptoms including fever, chills, coughing up blood, chest pain, and difficulty breathing. Often, patients who develop invasive aspergillosis are undergoing chemotherapy treatment for cancer, have received a bone marrow transplant, or have an immune system disorder.

In a clinical study, patients who received at least one dose of Noxafil to treat invasive aspergillosis had a lower all-cause mortality rate (15.3% vs. 20.6%) through Day 42 compared to patients who received voriconazole, a current standard of care. The global clinical treatment response rate at Week 6 was similar for both medications – 44.8% in patients who received Noxafil and 45.6% for patients who received voriconazole.

Recommended dosing under the new indication is a loading dose of 300mg given twice on the first day (for a total daily dose of 600mg), followed by a maintenance dose of 300mg once daily for a duration of 6-12 weeks regardless of whether the IV injection or delayed-release oral tablets are used. Patients can be switched between IV injection and delayed-release oral tablets without needing another loading dose.