The Food and Drug Administration (FDA) antimicrobial drugs advisory committee yesterday recommended the approval of rezafungin for the treatment of candidemia and invasive candidiasis in adults, the first new drug to treat the conditions in over a decade.
Cidara Therapeutics, based in San Diego, developed the drug and has signed a licensing agreement with Melinta Therapeutics to market and distribute rezafungin—an echinocandin antifungal—in the United States. The FDA committee's recommendation passed by a 14-to-1 vote. The committee's vote isn't binding, but the FDA often accepts the recommendations of its advisory groups when making its approval decisions. Cidara submitted the drug for review last July, and the FDA has granted it a priority review.
Jeffrey Stein, PhD, Cidara's president and chief executive office, said in a company statement that the committee's recommendation is a significant step toward the goal of providing a once-weekly treatment option for patients who have invasive Candida infections.
The FDA panel based its recommendation on encouraging phase 3 and phase 2 trials, along with extensive nonclinical findings. When given once-weekly to patients, rezafungin demonstrated statistical noninferiority when compared to caspofungin, the current standard of care that is given once daily. The results of the studies met the primary end points defined by the FDA and the European Medicines Agency.