Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.
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Use should be targeted for patients with candidemia/invasive candidiasis who require longer-term therapy and for whom daily intravenous administration with currently approved echinocandins is problematic, Antimicrobial Drugs Advisory Committee says.
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.
Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.