Rezzayo is a novel once-weekly antifungal to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain. It will have a wholesale acquisition cost of $1,950 per vial.
Melinta Therapeutics has launched Rezzayo (rezafungin), which was approved by the FDA in March 2023 to treat patients 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 over a decade.
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 part of the echinocandin class of antifungal drugs, which has been found to cause milder side effects than azole antifungals. While echinocandins have been available since the early 2000s, their use has been primarily limited to the hospital in-patient setting due to their requirement of daily IV infusions. Rezzayo is administered as a once weekly infusion, and it will have a wholesale acquisition cost of $1,950 per vial, the company told Formulary Watch.
“It’s a much-needed option for physicians and those patients who may be able to transition out of the hospital sooner,” John Harlow, chief commercial officer for Melinta Therapeutics, said in a press release.
The FDA approved Rezzayo in March 2023. 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 2023. Rezzayo demonstrated comparable efficacy and safety to caspofungin (Merck’s Cancidas) and no clinically meaningful drug-drug interactions.