Cidara’s Rezafungin Hits Approvable Endpoints For Candida Infections
Phase III data for the novel echinocandin demonstrated non-inferiority to caspofungin for all-cause mortality at day 30 and for global cure at day 14. Regulatory filings are planned for 2022.
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Cidara’s US commercial partner Melinta will launch the novel echinocandin this summer, announcing pricing shortly before rollout. Limited indication follows recommendation of FDA advisory panel.
Antimicrobial Drugs Advisory Committee will consider whether overall benefit-risk assessment is favorable for treatment of candidemia/invasive candidiasis in adults with limited or no treatment options and, if so, the clinical scenario in which rezafungin fulfills an unmet need.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker