(Reuters) – The U.S. Food and Drug Administration (FDA) on Monday approved the drug rezafungin, from Sidara Therapeutics (CDTX.O), for the treatment of a range of severe fungal infections most commonly faced by hospitalized patients. It has been approved as a drug, the company said. .
The FDA has approved the drug to treat infections in adult patients. Recommendation Created in January by a panel of outside experts from the agency, it voted 14 to 1 in favor of drug use.
Rezafungin, branded Rezzayo, is given once a week as part of the current standard of care to patients who normally must rely on daily dosing.
Antibiotic maker Melinta Therapeutics has commercial rights to the drug in the U.S. market and plans to make rezafungin available this summer.
Melinta CEO Christine Miller told Reuters before the FDA’s decision was made that the company will announce a list price for the drug closer to that time.
Rezzayo belongs to a class of drugs known as echinocandins that are recommended by the Infectious Diseases Society of America as first-line therapy for fungal infections.
Later studies showed the drug was no worse than the current standard of care, Cidara said.
Steve Brozac, managing partner at WBB Securities, said the drug has the potential to be a big hit in treating fungal infections that are “silent killers” and that no cases have been recorded.
HC Wainwright & Co had projected peak annual US sales for the drug at approximately $219 million prior to the decision.
According to government estimates, approximately 25,000 cases of candidaemia occur in the United States each year.
Candidemia infections are caused by Candida, a yeast that normally lives inside the body and skin without problems, entering the bloodstream. Invasive candidiasis is when candida spreads from the bloodstream to the heart, brain, eyes, or other body parts.
Reported by Aditya Samal and Raghav Mahobe. Edited by Uttaresh Venkateshwaran and Shounak Dasgupta
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