Breakthrough Drug for Treatment of Candidemia, Invasive Candidiasis Patients
Cidara Therapeutics and Melinta Therapeutics have collaborated to launch REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in people who have limited or no other therapeutic choices.
This novel medicine has been approved by the US Food and Medicine Administration, which is a huge step forward.
REZZAYO is notable for being the first newly approved therapy option for patients with candidemia and invasive candidiasis in over ten years.
The FDA approved once-weekly REZZAYO on the basis of clinical data from Cidara's worldwide ReSTORE Phase 3 trial, which was backed up by the STRIVE Phase 2 clinical trial and an extensive non-clinical development programme.
REZZAYO, when administered once weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority to caspofungin, the current once-daily standard of therapy.
Furthermore, the overall rates of adverse events and serious adverse events in patients receiving REZZAYO and caspofungin were identical, as were the rates of adverse events resulting to study drug termination. REZZAYO was authorised under Priority Review based on its Qualified Infectious Disease Product (QIDP) designation.
REZZAYO (rezafungin injectable) is a unique once-weekly echinocandin licenced for the treatment of candidemia and invasive candidiasis in adults in the United States.
REZZAYO is now being researched in people having allogeneic blood and marrow transplantation for the prevention of invasive fungal infections. REZZAYO's structure and characteristics are precisely intended to enhance a clinically established mechanism.
REZZAYO is an echinocandin antifungal approved for the treatment of candidemia and invasive candidiasis in individuals 18 years of age and older who have limited or no other choices. This indication was approved based on minimal clinical safety and effectiveness data.
REZZAYO is notable for being the first newly approved therapy option for patients with
candidemia and invasive candidiasis in over ten years.
The FDA approved once-weekly REZZAYO on the basis of clinical data from Cidara's
worldwide ReSTORE Phase 3 trial, which was backed up by the STRIVE Phase 2 clinical trial
and an extensive non-clinical development programme.
REZZAYO, when administered once weekly, met the FDA and EMA primary endpoints,
demonstrating statistical non-inferiority to caspofungin, the current once-daily standard of
therapy.
Furthermore, the overall rates of adverse events and serious adverse events in patients receiving
REZZAYO and caspofungin were identical, as were the rates of adverse events resulting to study
drug termination. REZZAYO was authorised under Priority Review based on its Qualified
Infectious Disease Product (QIDP) designation.
REZZAYO (rezafungin injectable) is a unique once-weekly echinocandin licenced for the
treatment of candidemia and invasive candidiasis in adults in the United States. REZZAYO is
now being researched in people having allogeneic blood and marrow transplantation for the
prevention of invasive fungal infections. REZZAYO's structure and characteristics are precisely intended to enhance a clinically established mechanism.
REZZAYO is an echinocandin antifungal approved for the treatment of candidemia and invasive
candidiasis in individuals 18 years of age and older who have limited or no other choices. This
indication was approved based on minimal clinical safety and effectiveness data.
