Cidara and Melinta Win FDA Approval for First New Echinocandin in a Decade
Photo shows FDA sign in front of building/Sarah Silbiger/Getty Images
Wednesday, the FDA approved Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin) injection to treat candidemia and invasive candidiasis.
Rezzayo, a once-weekly injection, is the first new echinocandin approved in more than a decade, according to the press release.
This follows a warning issued by the CDC Monday of an emerging fungus that is resistant to antimicrobials in U.S. healthcare facilities.
First reported in 2016, Candida auris (C. auris) is generally not a threat to healthy people, according to the CDC. But those who are very ill or use invasive medical devices are at increased risk. The health authority reported a tripling of cases in 2021 that were resistant to echinocandins, the primary drugs used to treat infection.
Rezzayo is currently indicated for use in adults with limited or no alternative treatment options for candidemia and invasive candidiasis.
In a Phase III trial, Rezzayo proved non-inferior to the standard of care, once daily caspofungin, with a comparable safety profile. The approval was granted under the FDA’s Priority Review program.
John Harlow, chief commercial officer at Melinta, told BioSpace how Rezzayo differs from the standard of care.
"Rezzayo is differentiated in that it can be administered through weekly IV dosing as opposed to daily infusions which are needed with the current standard of care," he said. "Additionally, its pharmacokinetics allow for front-loaded dosing that provides faster time to fungal clearance in the clinic, less potential for resistance development due to high initial drug exposure and less potential for underdosing."
Candidemia, a Candida infection in the bloodstream, is the most common form of invasive candidiasis and one of the most common causes of bloodstream infections in hospitalized patients. It often results in longer hospital stays and even death. One study estimated candidemia-attributed mortality to be 19-24%.
Melinta intends to leverage its "expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings” where it's needed most, Christine Ann Miller, CEO, Melinta, said in the press release.
The companies expect to launch Rezzayo in the U.S. by summer 2023.
Rezzayo is also in studies to prevent fungal diseases in adults undergoing allogeneic blood and marrow transplants.
The antifungal is Cidara’s first marketed drug and the seventh approved in Melinta’s commercial portfolio.
Melinta acquired exclusive rights to commercialize the drug in the U.S. last year, while Cidara retains rights in Japan. Mundipharma has licensed the injectible for all other areas. The EMA is currently reviewing the application for approval in Europe.
Rezzayo’s approval triggers a $20 million milestone payment to Cidara under terms of its agreement with Melinta, with another $40M in regulatory and up to $370M in commercial milestone payments still on the line.