The drug, branded as Rezzayo, is the first FDA-approved invasive candidiasis treatment in over a decade.
Rezafungin for injection (Rezzayo) has been approved by the FDA to treat candidemia and invasive candidiasis in adults with limited or no other treatment options. Melinta Therapeutics and Cidara Therapeutics announced the approval in a joint press release1 last week.
The treatment is a “novel, once-weekly, next-generation echinocandin, ”and it was approved under Priority Review based on its Qualified Infectious Disease Product designation. This is the first new invasive candidiasis treatmentsince anidulafungin (Eraxis) was approved in 2006.
“The FDA approval of Rezzayorepresents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis, ”Jeffrey Stein, PhD, president and CEO of Cidara, said in the press release.
The recommended dosage is a once weekly intravenous infusion of an initial 400 mg loading dose followed by a 200 mg weekly dose. The safety ofrezafungin for injection has not been established beyond 4 weekly doses, according to the prescribing information.
Invasive candidiasis occurs when yeast called candida gets into an individual’s bloodstream and then spreads throughout the rest of their body, whether it’s their bone, brain, eyes, kidney, liver, and can become life-threatening along the way.
According to theCenters for Disease Control (CDC),2 “approximately 25,000 cases of candidemia occur nationwide each year.” However, while “it is the most common form of invasive candidiasis, candidemia does not represent all forms of invasive candidiasis.”
The CDC consistently monitors the threat of candidemia throughout the United States. Those threat levels change dramatically based on geographic location, so the CDC supplies more surveillance and attention to areas with higher injection drug use, “which has recently re-emerged as a risk factor for candidemia.”
During trials, rezafungin for injection was tested against caspofungin, a once-dailycare for invasive candidiasis that has been available for use since 2001. “Rezzayo, dosed once-weekly, met the FDA and [European Medicines Agency] primary endpoints, demonstrating statistical non-inferiority” when compared with caspofungin, the current once-daily standard of care, Melinta and Cidara noted in the release.
The companies said that “adverse events and serious adverse events were comparable in patients receiving Rezzayo and caspofungin. ”The most common adverse reactions, with an incidence of 5% or greater, were hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
“We are thrilled that the FDA has approved Rezzayo, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections,” said Christine Ann Miller, president and CEO of Melinta Therapeutics.
A new treatment with the ability to simplify and advance fungal infection treatment is welcome news, said George Thompson, MD, a professor of clinical medicine at the University of California Davis School of Medicine. “The FDA approval of Rezzayois tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections,” he said. “Based on the totality of clinical data generated, Rezzayohas the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”
This treatment approvalwill be welcome news to patients who can potentially avoid the exorbitant hospital costs associated with candida infections, as well. “Each case of candidemia is estimated to result in an additional 3 to 13 days of hospitalization and $6,000 to $29,000 in healthcare costs,” according to the CDC.
Rezzayo is expected to become available in summer of 2023.