FDA advisors back Cidara antifungal rezafungin
An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade.
The panel voted 14 to 1 that the benefits of Cidara and Melinta Therapeutics’ once-weekly echinocandin drug outweighed its risks as a first-line treatment for candidemia and invasive candidiasis in adults who have limited or no alternative treatment options.
The decision puts Cidara and Melinta on course for a positive outcome when the FDA delivers its verdict on the filing, which is due by 22 March. If approved it will be sold by Melinta, which licensed US rights to it last July and already markets a range of antibacterial drugs.
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