MHRA (UK) approval of Rezzayo (rezafungin acetate) for the treatment of invasive candidiasis in adults.- Cidara Therapeutics and MundiPharma.
Cidara Therapeutics, Inc announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved Rezzayo (rezafungin acetate) for the treatment of invasive candidiasis in adults.
“Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.”
This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the FDA and European Commission (EC).
Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.