FDA Clears First New Treatment for Invasive Candidiasis in 10 Years

The FDA has cleared Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin for injection) to treat candidemia and invasive candidiasis in adults with limited or no alternative treatment options. It is the first new treatment option approved for patients with candidemia and invasive candidiasis in more than a decade, the two companies said.

Candida infections are caused by yeast, and infection can happen in the mouth and throat (thrush) or vaginal yeast infections. Invasive candidiasis, however, is a serious infection that can affect the blood, heart, brain, eyes, bones or other parts of the body. A Candida bloodstream infection, also called candidemia, is the most common form of invasive candidiasis, and can result in long hospital stays, according to the CDC.

Rezzayo is a novel once-weekly echinocandin antifungal. It will be available to healthcare professionals and patients this summer, so the company anticipates announcing the list price of Rezzayo closer to that time, Melinta Therapeutics told Formulary Watch.

There is an increasing threat and resistance of the Candida species, according to a presentation to FDA’s Antimicrobial Drugs Advisory Committee Meeting in January. Rezzayo demonstrated comparable efficacy and safety to caspofungin (Merck’s Cancidas) and no clinically meaningful drug-drug interactions. In January 2023, the advisory committee voted favorably 14 to 1 that the evidence supported the risk-benefit.

George Thompson, M.D.

“The FDA approval of Rezzayo is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections,” George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California - Davis School of Medicine, said in a press release. “Based on the totality of clinical data generated, Rezzayo has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”

Additionally, its once-weekly IV dosing allows for earlier removal of catheter and outpatient treatment for those unable to maintain IV access and for whom oral therapy is inappropriate, the companies said in the presentation.

FDA’s approval of once-weekly Rezzayo was based on clinical data from Cidara’s global ReSTORE phase 3 trial and supported by the STRIVE phase 2 clinical trial and extensive non-clinical development program.

Melinta plants to leverage its “expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings,” said Christine Ann Miller, president and CEO of Melinta. Last year, Melinta announced that it had acquired the exclusive rights to commercialize Rezzayo in the United States from Cidara. Cidara retains the rights to rezafungin in Japan.

The novel echinocandin is also being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.