Cidara’s Anti-Fungal Receives Approval with Priority Review from US FDA

March 23, 2023

Rezzayo, Cidara Therapeutics’ newest anti-fungal drug, has received the nod from the US Food and Drug Administration (FDA) for approval under priority review for two kinds of candida infections, candidemia and invasive candidiasis. The drug is currently being reviewed by the EMA, which has already granted its marketing authorization approval.

According to Katherine Lewin, “In January, the FDA’s Antimicrobial Drugs Advisory Committee voted 14-1 in favor of a limited-use indication for the drug based on two trials that showed statistical non-inferiority versus caspofungin, the current standard. Caspofungin, sold under the brand name Cancidas by Merck, was approved in 2011 for adults and pediatric patients to treat candida infections, invasive candidiasis, febrile neutropenia, esophageal candidiasis and invasive aspergillosis. It belongs to a class of antifungal drugs called echinocandin.”

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(Source: Endpoints News, March 23rd, 2023)

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