FDA Panel Backs New Antifungal Isavuconazonium (Cresemba)
Ever since there have been mold sufferers, there have been skeptics who don’t believe mold makes people sick. But now there’s a drug especially for those who suffer mold allergies. If the problem didn’t exist, there wouldn’t be a drug for it. Cresemba is under review in the U.S. for the treatment of invasive mucormycosis and aspergillosis.
Cresemba has what is called orphan drug status and has a Qualified Infectious Disease Product (QIDP) designation in the U.S. for both indications. A panel of experts voted Thursday unaninmously to recommend Cresemba to the FDA.
Doctors currently believe that healthy people are not affected by invasive aspergillosis, but those who are sick, in chemotherapy, the elderly, infants, and the immune-compromised are at risk.
The advisory committee examined studies on the new drug, and does recommend more research to be completed. The committee is peopled by experts such as Dean Follmann, assistant director for Biostatistics at the National Institute of Allergy and Infectious Diseases, and Dr. Paige Waterman who is in Antimicrobial Resistance at the Armed Forces Health Surveillance Center at the Walter Reed Army Institute of Research.