Cidara gets US FDA approval for antifungal drug
By Aditya Samal and Raghav Mahobe
March 22 (Reuters) – The U.S. Food and Drug Administration (FDA) on Wednesday approved Cidara Therapeutics Inc’s (CDTX.O) drug, rezafungin, to treat a group of severe fungal infections that are most commonly faced by hospitalized patients, the company said.
FDA approved the drug to treat the infections in adult patients with limited or no alternative treatment options, in line with recommendations made in January by the agency’s panel of outside experts, who voted 14-1 in favor of the drug’s use.
Rezafungin, branded as Rezzayo, is dosed once a week for patients, who usually have to depend on daily doses as part of current standard-of-care treatment.
Antibiotics maker Melinta Therapeutics, which has commercialization rights for the drug in the U.S. market, plans to make rezafungin available this summer.
The company will announce the drug’s list price closer to that time, Melinta CEO Christine Miller told Reuters before the FDA decision.
Rezzayo belongs to a class of drugs known as echinocandin, which are recommended as first-line therapy for fungal infections by the Infectious Diseases Society of America.
In a late-stage study, the drug showed it was no worse compared with the current standard of care, according to Cidara.
There was a blockbuster potential for the drug to treat the “silent killer” fungal infections, cases of which are under-recorded, WBB Securities’ Managing Partner Steve Brozak said ahead of the approval.
H.C. Wainwright & Co projected peak annual revenue from U.S. sales of the drug at nearly $219 million before the decision.
Government estimates show around 25,000 cases of candidemia occur in the United States each year.
Candidemia infection is caused when a yeast, candida, which generally lives inside the body or skin without causing any problems, enters the bloodstream. Invasive candidiasis is when candida spreads from the bloodstream to the heart, brain, eyes or other body parts.