The medication Rezzayo®, containing the antifungal agent Rezafungin, has secured approval in the European Union for the treatment of invasive candidiasis in adults. Rezafungin belongs to the Echinocandin class of antifungals, making it the first representative of this substance class to be administered once weekly.
Invasive candidiasis is a severe, life-threatening infection affecting the bloodstream and/or deep/visceral tissues. It primarily impacts individuals with compromised immune systems, and the mortality rate is notably high.
Understanding Rezafungin’s Mechanism
Rezafungin, classified as an Echinocandin, shares its class with antifungals like Caspofungin, Micafungin, and Anidulafungin. The drug’s mechanism of action is not novel; as an Echinocandin, it selectively inhibits the 1,3-β-D-glucan synthase of the fungus. This inhibition prevents the formation of 1,3-β-D-glucan, a crucial component of the fungal cell wall absent in mammalian cells.
Consequently, the inhibition of 1,3-β-D-glucan synthesis leads to rapid and concentration-dependent fungicidal activity against Candida species (spp.).
According to Mundipharma, the provider of Rezzayo, the medication is set to be introduced to the market in Germany in the first quarter of 2024. The EU approval is grounded in the outcomes of the Phase III study ReSTORE, demonstrating the non-inferiority of Rezafungin, administered once weekly, compared to the current therapy standard Caspofungin, administered once daily. Commonly observed side effects in clinical studies include hypokalemia, fever, and diarrhea.
Administration and Treatment Duration
Rezafungin, like other Echinocandins, is administered through infusion. On the first day, an initial dose of 400 mg is given as a single infusion, followed by 200 mg on day 8 and then once weekly thereafter. The duration of treatment should align with the patient’s clinical and microbiological response.
The approval of Rezzayo provides a promising addition to the treatment options for invasive candidiasis, offering a convenient once-weekly dosing regimen. As the pharmaceutical landscape evolves, this advancement brings new hope for patients and healthcare providers in managing this critical condition.
Original source: This information was Initially covered by PZ.de and has been translated for our readers.
