FDA Approves Cresemba for Serious Fungal Infections

Share this content:
FDA Approves Cresemba for Serious Fungal Infections
FDA Approves Cresemba for Serious Fungal Infections

MONDAY, March 9, 2015 (HealthDay News) -- Cresemba (isavuconazonium sulfate) has been approved by the U.S. Food and Drug Administration to treat invasive aspergillosis and invasive mucormycosis, the agency said Friday in a news release.

These rare but serious fungal infections mostly affect people with weakened immune systems. The new drug, targeting the cell walls of the fungi, is available in oral and intravenous formulations.

Cresemba's safety and effectiveness were evaluated in clinical studies involving more than 500 people. The most common side effects included nausea, vomiting, diarrhea, headache, hypokalemia, constipation, dyspnea, coughing, and peripheral edema. More serious adverse effects could include liver problems and allergic reactions.

"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," Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Cresemba is marketed by Astellas Pharma US, based in Northbrook, Ill.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

FDA Permits Marketing of Brain Stimulation Device for OCD

FDA Permits Marketing of Brain Stimulation Device for ...

FDA previously approved transcranial magnetic stimulation for major depression, certain migraines

Comments Open on End of NIH Review for Gene Therapy Studies

Comments Open on End of NIH Review for ...

NIH oversight panel no longer plans to review all applications for gene therapy experiments

U.S. Measles Outbreak Hits 107 Cases in 21 States, D.C.

U.S. Measles Outbreak Hits 107 Cases in 21 ...

Outbreak on track to exceed last year's; most of the people who got measles weren't vaccinated

is free, fast, and customized just for you!




Already a member?

Sign In Now »