MHRA accepts Napp's rezafungin MAA submission

Cambridge, UK-based Napp Pharmaceuticals today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing authorization application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.

The application is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once-weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.

If approved by the MHRA, rezafungin could be the first new treatment option in Great Britain for patients with candidemia or invasive candidiasis for over 10 years and would be supplied by Napp Pharmaceuticals, part of the Mundipharma global network of independent associated companies.