- The Food and Drug Administration on Wednesday approved the first new drug in more than a decade for patients with candidemia and invasive candidiasis.
- Cidara Therapeutics developed the treatment, a once-weekly injection to be sold as Rezzayo. Melinta Therapeutics, which acquired the U.S. rights to the antifungal therapy last year, expects to be able to offer the drug to patients this summer.
- There’s a significant need for new treatments for the conditions stemming from the Candida fungus, and an FDA advisory committee voted 14-1 to back the drug in January despite reservations laid out by agency reviewers about Cidara’s data. The clearance comes as public health officials increasingly sound the alarm about one type of species known as Candida auris that’s often resistant to available drugs.
Rezzayo is part of a class of medications known as echinocandins, which are usually the first drugs used to treat patients suffering from bloodstream infections caused by Candida. Unlike the three approved medicines in the class, Rezzayo doesn’t require a daily injection.
The FDA approved Rezzayo for patients who have limited or no alternative treatment options based on Cidara research that the drug’s effects measured up to an existing medicine known as caspofungin. The new option has the potential to simplify treatment for patients, according to a statement from the principal researcher in Cidara’s pivotal trial, George Thompson of the University of California, Davis.
Still, it’s unclear how much Rezzayo and other echinocandins will be able to help combat the current concern with C. auris. Even as the Centers for Disease Control and Prevention warned Monday that C. auris was spreading at an “alarming rate” in healthcare facilities, the agency said it was equally concerned that the number of cases resistant to echinocandins had tripled in 2021.
First reported in the U.S. in 2016, C. auris cases have increased each year since. They started a rapid ascent in 2020 and 2021, likely worsened by the strain COVID-19 put on the medical system. The CDC reported 3,270 clinical cases of C. auris through the end of 2021, along with 7,413 cases in which the Candida species was found but did not cause symptoms.
Cidara and Melinta aren’t alone in seeing the need for new treatments for fungal infections. In 2021, Pfizer bought privately held Amplyx Pharmaceuticals to gain new antifungal and antiviral treatments.