The U.S. Food and Drug Administration has okayed Cresemba (isavuconazonium sulfate), a new antifungal medicine product used to treat people with invasive aspergillosis and invasive mucormycosis, unusual but serious infections.
Aspergillosis is a fungal infection triggered by Aspergillus species, and mucormycosis is triggered by the Mucorales fungi. These infections take place most usually in individuals with weakened immune systems.
Cresemba connected to a class of drugs known as azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and IV formulations.
“Today’s acceptance offers a new therapy choice for individuals with serious fungal infections and underscores the significance of having accessible safe and efficient antifungal medicines,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Cresemba is the 6th accepted antibacterial or antifungal drug product specified as a Qualified Infectious Disease Product (QIDP). This status is provided to antibacterial or antifungal drug products that deal with serious or life-threatening infections within the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
As part of its QIDP designation, Cresemba was provided priority review, which offers an expedited evaluation of the drug’s application. The QIDP status also enables Cresemba for an additional five years of marketing exclusivity to be included to certain exclusivity periods already offered by the Food, Drug, and Cosmetic Act. As these kinds of fungal infections are unusual, the FDA also provided Cresemba orphan drug status for invasive aspergillosis and invasive mucormycosis.
The acceptance of Cresemba to cure invasive aspergillosis was dependent on a clinical study involving 516 individuals randomly allocated to get either Cresemba or voriconazole, another drug accepted to treat invasive aspergillosis. Cresemba’s acceptance to treat invasive mucormycosis was dependent on a single-arm clinical study involving 37 individuals treated with Cresemba and in comparison with the natural disease progression related with untreated mucormycosis. Both studies revealed Cresemba was safe and effective in treating these serious fungal infections.
The very common side effects connected with Cresemba consist of nausea, abnormal liver blood tests, shortness of breath, vomiting, diarrhea,coughing and tissue swelling, headache, low potassium levels in the blood, constipation, Cresemba may also lead to severe side effects such as liver issues, infusion reactions and serious allergic and skin reactions.