Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases
The FDA accepted CorMedix's sNDA for REZZAYO (rezafungin) for prophylaxis of invasive fungal disease and granted Priority Review, with a PDUFA target action date in Q1 2027. The filing, submitted by global development partner Mundipharma, is supported by the positive Phase III ReSPECT study in adults undergoing allogeneic HSCT.
Key figures
- Drug Name
- REZZAYO (rezafungin for injection)
- Phase Of Trial
- Phase III
- Patent coverage through
- 2038
- Pdufa target action date
- Q1 2027
- Potential promotion start
- H2 2027
- Orphan exclusivity through
- 2035
AI analysis
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