Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency

Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency

For UK Trade and Medical Media Only

• Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections
• The Medicines and Healthcare Products Regulatory Agency (MHRA) filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin demonstrated non-inferiority to the current standard of care in the treatment of candidemia and/or invasive candidiasis[i]
• If approved by the MHRA, rezafungin could be the first new treatment option in Great Britain (GB) for patients with candidemia or invasive candidiasis for over 10 years and would be supplied by Napp Pharmaceuticals Limited* (Napp) in GB.

CAMBRIDGE, England, 16 November 2022: Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. The marketing authorisation 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.¹

Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.[ii] Despite current treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%.[iii] Antifungal drug resistance is becoming an increasing concern, with 90% of Candida auris strains showing resistance to fluconazole, one of the major treatment options. Echinocandin resistance is currently uncommon (5–10%).⁴ There is a real need for new treatment options to address this serious disease, especially as there has been no significant additional treatment options over the last decade.

In the ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) marketing authorisation application of global cure at Day 14.  The MHRA has agreed they will accept the EMA primary endpoint.

“If approved, rezafungin, as a novel, once-weekly echinocandin, could bring new hope for critically ill, vulnerable patients battling with this difficult-to-treat and often deadly disease,“ said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “With the rise in multidrug-resistant Candida strains in hospitals, this MHRA marketing authorisation submission is a positive step, and we hope we will be able to work with the MHRA to bring this medicine to patients who need it.”

Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US.5^,6  It has been identified as a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA),⁷ which confers both Fast Track and Priority Review status and has been accepted for marketing authorisation review by the EMA.  In the US, the FDA has granted Priority Review to Cidara Therapeutics New Drug Application for rezafungin for the treatment of candidemia and invasive candidiasis.⁸

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the US and Japan.