Astellas nabs FDA approval for new antifungal
- The FDA has approved Astellas' antifungal Cresemba (isavuconazonium sulfate). It is the sixth approved drug under the agency's Qualified Infectious Disease Product (QIDP) designation.
- Cresemba is an azole antifungal.
- Cresemba is available in both oral and intravenous formulations.
Although Cresemba is the sixth approved drug under the FDA's QIDP designation, there continues to be a serious unmet medical need for drugs to treat fungal infections, such as invasive mucormycosis. Cresemba's efficacy in treating mucormycosis was based on a single-arm trial involving 37 subjects, and was deemed both safe and effective based on the trial's results.
Nonetheless, there are intense side effects associated with Cresemba, including nausea, vomiting, diarrhea, headache, abnormal liver blood tests, low potassium levels in the blood and other adverse events.
Certain antifungal meds had come under consumer group scrutiny in recent weeks over dangerous side effects, including ketoconazole pills from Teva and Mylan.