FDA approves cresemba for serious fungal infections

FDA approves cresemba for serious fungal infections

(HealthDay)—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 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: More Information

Health News Copyright © 2015 HealthDay. All rights reserved.

Citation: FDA approves cresemba for serious fungal infections (2015, March 9) retrieved 19 March 2024 from https://medicalxpress.com/news/2015-03-fda-cresemba-fungal-infections.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Explore further

FDA: Akynzeo approved for chemo-related nausea / vomiting

6 shares

Feedback to editors