Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval for Rezafungin for Candidemia and Invasive Candidiasis Treatment

Cidara Therapeutics and Melinta Therapeutics announced that the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration (FDA) authorised rezafungin to treat candidemia and invasive candidiasis in adult patients by a vote of 14 to 1. The FDA’s advisory committee determined that rezafungin’s New Drug Application contained sufficient evidence to support a favourable risk-benefit assessment of the therapy.

Publish Date: 25-01-2023 Source: Cidara Therapeutics

Invasive candidiasis is an infection caused by a type of fungus called Candida is a serious infection that can affect the blood, bones, brain, eyes, heart, and other parts of the body. Candida species are frequent colonizers of the human alimentary tract and skin that have emerged as important nosocomial pathogens, in tandem with advances in modern medical therapeutics. Risk factors for invasive candidiasis include exposure to broad-spectrum antibiotics and cancer chemotherapy, advanced care of premature neonates, major abdominal surgery, organ transplantation, prolonged stay in an intensive care setting, and implanted medical devices such as vascular catheters and prosthetic heart valves, and parenteral feeding. Recent treatment directives have been shaped by the widespread introduction of echinocandins, highly potent and safe antifungals, into clinical use, essential changes in drug susceptibility patterns, and the emergence of known and novel drug-resistant drugs Candida species. Advances in molecular diagnostics have the potential to guide the early targeted treatment of high-risk patients.

The global incidence cases of Invasive candidiasis have been estimated between 550,000 to 825,00 cases annually, with an associated crude mortality rate varying between 22% to 43%.

However, the current Invasive candidiasis treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (SCY-078, APX001, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Invasive candidiasis treatment. The key companies in the advanced development stage are Scynexis, Inc., Amplyx Pharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Invasive candidiasis to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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