Cidara Therapeutics wants to make its mark in the world of antifungals, and thanks to the FDA, it may get there soon.
The San Diego-based company announced Tuesday that the FDA has given priority review to its antifungal rezafungin for the treatment of candidemia and invasive candidiasis — common causes of serious bloodstream infections in hospitalized patients, per the CDC. No new therapies have been approved in over a decade for the two infections, the company said in a press statement. Rezafungin’s review deadline date is set for Feb. 28, 2023.
The new drug submission was based on results from its global ReSTORE Phase III and STRIVE Phase II trials, which showed the drug’s non-inferiority over caspofungin, the current standard of care.
“If approved, rezafungin would represent an important new treatment option for patients at risk of these potentially deadly diseases,” said Cidara’s CEO Jeffrey Stein.