FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
28 Mar 2023 • The U.S. FDA has approved rezafungin for injection, (REZZAYO), a treatment for patients with candidemia and invasive candidiasis. The new treatment is the first approved for the invasive fungal infection in over a decade. It is a novel antifungal therapy given once a week intravenously. A Candida bloodstream infection, also referred as candidemia, is the most common form of invasive candidiasis, and can result in prolonged hospital stays, according to the CDC.
The FDA approval of rezafungin for injection was based on clinical data from a Phase 3 trial called ReSTORE.
- The double-blind trial was done at 66 tertiary care centers in 15 countries
- Adults 18 years of age or older with invasive candidiasis were randomly assigned to receive one of two treatments
- About half got rezafungin for injection once a week (400 mg in week 1, followed by 200 mg weekly, for a total of two to four doses). The other half received intravenous caspofungin, the current standard of care that is given once daily (70 mg on day 1, followed by 50 mg daily) for no more than four weeks.
- 199 patients were randomly assigned to the rezafungin for injection group (100 patients) and the caspofungin group (99 patients).
- 55 of 93 patients in the rezafungin for injection group and 57 of 94 patients in the caspofungin group were cured at day 14.
- 55 patients in the rezafungin for injection group and 52 in the caspofungin group had serious adverse events.
- The most common treatment-emergent adverse events in at least 5% of patients in either group were fevers, low potassium levels, pneumonia, septic shock, and anemia.
“When analyzing the data, we saw when given once weekly to patients, rezafungin for injection showed similar results to caspofungin,” George Thompson, professor of infectious diseases at UC Davis Health explained.
Source: UC Davis Health | Read full story