- A panel of outside experts convened by the Food and Drug Administration have recommended a new antifungal treatment developed by Cidara Therapeutics that could become the first therapy drug approved in more than a decade for candidemia and invasive candidiasis.
- The FDA advisory committee voted 14-1 on Tuesday that the medicine, rezafungin, has a favorable risk-benefit ratio when given to adult patients who have limited or no other treatment options. While the FDA doesn’t have to follow the recommendations of its expert panels, it usually does.
- Melinta Therapeutics, which has a number of approved antibacterial medicines, is set to sell rezafungin in the U.S. after acquiring licensing rights in July from Cidara. The companies expect an answer from the FDA on marketing clearance by March 22.
Leading up to the advisory committee meeting, the FDA raised concerns about the amount of research Cidara submitted to support approval of its drug. Agency reviewers said they didn’t agree with the company’s proposal to pool data from both Phase 2 and Phase 3 studies and expressed concern that not enough patients had been treated to expose potentially rare side effects.
The FDA also highlighted an increased risk in tremors seen in both animal and human studies in briefing documents distributed ahead of the meeting. Still, the agency noted the benefit of the medication’s longer half life, which means patients need to receive an infusion only once a week compared with the daily intravenous treatments required by the three approved drugs in rezafungin’s class.
There’s also a significant need for new antifungal and antibacterial medicines as microbes increasingly develop resistance to older drugs.
Cidara’s Phase 3 study compared rezafungin with caspofungin, a drug approved in the U.S. in 2001 and sold under the brand name Cancidas by Merck. The company announced top-line results in December 2021, saying the experimental treatment matched up on a measurement called “non-inferiority” to the established product and had a similar safety profile.
Melinta signed on seven months later. Like other antibiotic and antifungal companies, Melinta has struggled in recent years with the development costs for a market often unwilling to pay high prices even for desperately needed new treatments. The company’s stock was delisted from the Nasdaq in 2020.
Cidara retained the rights to rezafungin in Japan and licensed rights in other areas of the world to Mundipharma.