FDA Approves Rezafungin Injection for the Treatment of Candidemia, Invasive Candidiasis

The FDA has approved rezafungin for injection (Rezzayo; Cidara Therapeutics Inc, Melinta Therapeutics LLC) for the treatment of candidemia and invasive candidiasis in individuals with limited or no alternative treatment options.

Rezafungin is the first new treatment option approved for individuals with candidemia and invasive candidiasis in more than a decade. It is currently being studied for the prevention of invasive fungal diseases in individuals undergoing allogeneic blood and marrow transplantation.

“The FDA approval of [rezafungin for injection] represents 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 a statement.

The approval of the once-a-week injection was based on clinical data from the ReSTORE (NCT03667690) phase 3 trial and supporting data from the STRIVE (NCT02734862) phase 2 clinical trial, as well as extensive non-clinical development program. The results of the clinical study for rezafungin for injection met the FDA and European Medicines Agency (EMA) primary endpoints, demonstrating statistical non-inferiority compared to caspofungin, the current standard of care taken once daily.

“The FDA approval of [rezafungin for injection] is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, [rezafungin for injection] has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care,” George Thompson, MD, professor of clinical medicine at the University of California School of Medicine, said in the statement.

Additionally, overall rates of adverse events (AEs) and serious AEs were comparable in individuals receiving rezafungin and caspofungin. The rates for AE-related discontinuation were similar for both drugs. Rezafungin for injection was approved under priority review based on Qualified Infectious Disease Product designation.

“We are thrilled that the FDA has approved [rezafungin for injection] 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. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing [rezafungin for injection], a differentiated once-weekly treatment to patients, this summer,” Christine Ann Miller, president and CEO of Melinta Therapeutics, said in the statement.

Melinta Therapeutics announced that it acquired the exclusive rights to commercialize rezafungin for injection in the United States from Cidara; however, Cidara still retains the rights to rezafungin for injection in Japan and has commercial rights to Melinta Therapeutics in the United States and Mindipharma in all other geographies. The EMA accepted the marketing authorization application for rezafungin for injection in August 2022 and is currently under review.

Rezafungin for injection is indicated for individuals aged 18 years and older and has not been studied in individuals with endocarditis, osteomyelitis, and meningitis due to Candida.

Reference

Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. News release. Cidara Therapeutics. March 22, 2023. Accessed March 23, 2023. https://www.cidara.com/news/cidara-therapeutics-and-melinta-therapeutics-announce-fda-approval-of-rezzayo-rezafungin-for-injection-for-the-treatment-of-candidemia-and-invasive-candidiasis/