The approval was based on the positive outcomes of the ReSTORE Phase 3 clinical trial in which rezafungin was found statistically non-inferior to the current standard of care
MHRA clears Napp Pharmaceuticals’ Rezzayo for invasive candidiasis. (Credit: fernando zhiminaicela from Pixabay)
Napp Pharmaceuticals has secured the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approval for its Rezzayo (rezafungin) to treat invasive candidiasis in adults in Great Britain.
Rezzayo is a once-weekly echinocandin that has been designed for the treatment of invasive candidiasis in adults.
The approval was based on the positive outcomes of the ReSTORE Phase 3 clinical trial.
Napp, part of the global healthcare company Mundipharma, said that ReSTORE compared the efficacy and safety of intravenous rezafungin with intravenous caspofungin in eligible patients with invasive candidiasis.
According to the results, rezafungin, administered once weekly, was statistically non-inferior to caspofungin, to the current standard of care, which is administered once daily.
In addition, these results were supported by the findings from the STRIVE Phase 2 clinical study and a nonclinical development programme.
Rezzayo was generally well tolerated in the trials and the common adverse reactions included hypokalaemia, pyrexia, and diarrhoea.
Mundipharma Northern Europe medical director Ben David said: “This authorisation is a culmination of years of developing an additional treatment option for eligible adult patients suffering from invasive candidiasis and underscores our commitment to supporting management of infectious diseases.”
ReSTORE is a multicentre, prospective, randomised and double-blind trial that had a primary efficacy outcome of global response at day 14. The global response was established from the clinical response, mycological response, and radiologic response.
At day 14, 59.1% of patients in the rezafungin group and 60.6% of patients in the caspofungin group out of the 187 patients in the modified intention-to-treat (mITT) population achieved a global response of cure.
In Great Britain, Rezafungin has been designated as an Orphan Drug Designation (ODD) to treat adult invasive candidiasis.
The company is currently conducting a second Phase 3 ReSPECT clinical trial of Rezzayo for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation.