Rezzayo™ (rezafungin) injection was approved by the U.S. Food and Drug Administration (FDA) on March 22, 2023. It is a next-generation antifungal drug in the echinocandin subclass. It is indicated for treating adult patients who have candidemia or invasive candidiasis that has few or no other treatment alternatives. Doses are administered by intravenous (IV) infusions once a week for up to four weeks, starting with one 400mg dose followed by 200mg doses. Rezzayo, which was developed by Cidara Therapeutics, will be distributed in the U.S. by Melinta Therapeutics beginning in the summer of 2023. The cost has not yet been announced. Full prescribing information for Rezzayo can be found at https://rezzayo.com/
At a Glance
- Brand (Generic) Name: Rezzayo (rezafungin)
- Manufacturer: Cidara Therapeutics/Melinta Therapeutics
- Date Approved: March 22, 2023
- Indication: to treat patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis
- Dosage Forms Available: single-dose vials containing 200mg of the drug (caked or powder) for reconstitution and IV infusion
- Launch Date: Summer 2023
- Estimated Annual Cost: Pricing information is not yet available.
- Limited infections with Candida, such as thrush and vaginal infections, are common. When the fungus enters the body, however, it can damage internal organs and cause death. The most common invasive type of candidiasis is candidemia, an infection of the blood.
- According to the Centers for Disease Control and Prevention (CDC), the U.S. has about 25,000 cases of candidemia annually. Most are for patients who are immunocompromised, who have an underlying condition such as diabetes or kidney failure, or who have been treated heavily with antibiotics.
- By interfering with an enzyme in fungal cell walls but not in human cells, echinocandin drugs, including Rezzayo, cause fungal cell walls to deteriorate.
- In clinical trials, both the effectiveness and the safety of Rezzayo were similar to those of caspofungin, a current echinocandin standard of care that is infused once a day until two weeks after the infection has cleared.
- Patients who use Rezzayo may be especially sensitive to ultraviolet (UV) rays from sunlight or artificial sources, such as tanning beds.
- Candida infections currently are treated with three subclasses of antifungals: azoles, such as fluconazole; polyenes, such as amphotericin B; and echinocandins. In some areas of the country, resistance to azoles and polyenes is relatively high compared with echinocandins.
- Rezzayo was given the FDA’s Priority Review. It also has Orphan Drug and Qualified Infectious Disease Product (QIDP) designations.