FDA: The U.S. Food and Drug Administration today approved Cresemba
(isavuconazonium sulfate), a new antifungal drug product used to treat
adults with invasive aspergillosis and invasive mucormycosis, rare but
serious infections.
Aspergillosis is a fungal infection caused by Aspergillus species,
and mucormycosis is caused by the Mucorales fungi. These infections
occur most often in people with weakened immune systems.
Cresemba belongs to a class of drugs called azole antifungal agents,
which target the cell wall of a fungus. Cresemba is available in oral
and intravenous formulations.
“Today’s approval provides a new treatment option for patients with
serious fungal infections and underscores the importance of having
available safe and effective antifungal drugs,” 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 sixth approved antibacterial or antifungal drug
product designated as a Qualified Infectious Disease Product (QIDP).
This designation is given to antibacterial or antifungal drug products
that treat serious or life-threatening infections under the Generating
Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation
Act.
As part of its QIDP designation, Cresemba was given priority review,
which provides an expedited review of the drug’s application. The QIDP
designation also qualifies Cresemba for an additional five years of
marketing exclusivity to be added to certain exclusivity periods already
provided by the Food, Drug, and Cosmetic Act. As these types of fungal
infections are rare, the FDA also granted Cresemba orphan drug
designations for invasive aspergillosis and invasive mucormycosis.
The approval of Cresemba to treat invasive aspergillosis was based on
a clinical trial involving 516 participants randomly assigned to
receive either Cresemba or voriconazole, another drug approved to treat
invasive aspergillosis. Cresemba’s approval to treat invasive
mucormycosis was based on a single-arm clinical trial involving 37
participants treated with Cresemba and compared with the natural disease
progression associated with untreated mucormycosis. Both studies showed
Cresemba was safe and effective in treating these serious fungal
infections.
The most common side effects associated with Cresemba include nausea,
vomiting, diarrhea, headache, abnormal liver blood tests, low potassium
levels in the blood (hypokalemia), constipation, shortness of breath
(dyspnea), coughing and tissue swelling (peripheral edema). Cresemba
may also cause serious side effects including liver problems, infusion
reactions and severe allergic and skin reactions.
Cresemba is marketed by Astellas Pharma US, Inc., based in Northbrook, Illinois.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.