FDA approves Cidara’s Rezzayo as antifungal treatment for candidemia and invasive candidiasis

Cidara Therapeutics’ antifungal Rezzayo (rezafungin) has been approved by the FDA under priority review for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options, the company announced Wednesday.

While the EMA accepted the marketing authorization application for rezafungin in August 2022, it is still under review for potential approval in Europe.

Melinta Therapeutics acquired the US rights to commercialize Rezzayo in the US last year, while Cidara has rights in Japan and Mundipharma “in all other geographies,” according to the press release.

Patients won’t have to wait long to be able to access Rezzayo, which the companies say is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

Christine Miller

“We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings,” Christine Miller, president and CEO of Melinta, said in a statement. “We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”

In January, the FDA’s Antimicrobial Drugs Advisory Committee voted 14-1 in favor of a limited-use indication for the drug based on two trials that showed statistical non-inferiority versus caspofungin, the current standard. Caspofungin, sold under the brand name Cancidas by Merck, was approved in 2011 for adults and pediatric patients to treat candida infections, invasive candidiasis, febrile neutropenia, esophageal candidiasis and invasive aspergillosis. It belongs to a class of antifungal drugs called echinocandin.

The company added in its statement that overall rates of adverse events and serious adverse events in the trials with Rezzayo were comparable to caspofungin, and that the drug has been approved “based on limited clinical safety and efficacy data.”

This could be just the beginning for Rezzayo indications. Cidara is conducting a Phase III trial for for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.

Earlier this month, Cidara collected approximately $19.5 million in a public offering of its common and preferred stock.

therapeutics
authorization
fda