Mundipharma’s rezafungin cleared by MHRA for invasive candidiasis in Great Britain

In a significant advancement for antifungal therapy, Napp Pharmaceuticals Limited, a key player within the international network of Mundipharma independent associated companies, has announced the authorization of Rezafungin by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of invasive candidiasis in adults in Great Britain. This approval is a testament to the positive outcomes demonstrated in the pivotal ReSTORE Phase III clinical trial, which evidenced the statistical non-inferiority of Rezafungin, administered once weekly, compared to the daily dosed standard of care, Caspofungin.

The authorization of Rezafungin is grounded in robust clinical evidence, including findings from the ReSTORE Phase III clinical trial and the STRIVE Phase II clinical trial, alongside an extensive nonclinical development program. The ReSTORE trial, a multicentre, prospective, randomised, and double-blind study, highlighted Rezafungin’s efficacy and safety in comparison to Caspofungin in treating eligible patients with invasive candidiasis. The trial’s primary efficacy outcome—global response at day 14—underscored Rezafungin’s potential as a viable and effective treatment option.

While Rezafungin has been generally well-tolerated in clinical trials, its safety profile includes common adverse reactions such as hypokalemia, pyrexia, and diarrhea, among others. Patients are advised to avoid sun exposure and other sources of UV radiation without adequate protection during treatment and for 7 days following the last administration of Rezafungin, due to an increased risk of phototoxicity.

Invasive candidiasis represents a severe, life-threatening infection, particularly impacting seriously ill individuals and those with weakened immune systems. The condition places a considerable burden on healthcare systems, necessitating extended treatment regimens and prolonged hospital stays. With limited advancements in treatment over the past 15 years and persistently high morbidity and mortality rates, the authorization of Rezafungin offers a much-needed alternative treatment pathway.

Professor P. Lewis White, a leading figure in the field of mycology, emphasized the difficulty in treating invasive candidiasis and the significance of introducing a new, once-weekly intravenous treatment option. Dr Ben David, Medical Director for Northern Europe at Mundipharma, reflected on the years of development leading to this authorization, highlighting the company’s dedication to enhancing infectious disease management.

Rezafungin’s approval is further distinguished by its grant of Orphan Drug Designation in GB, underscoring its potential to significantly benefit those affected by invasive candidiasis—a rare disease affecting fewer than 5 in 10,000 people in GB. This designation emphasizes the importance of developing treatments for rare diseases and disorders, reinforcing Mundipharma’s commitment to addressing unmet medical needs.

As Rezafungin embarks on its journey to become a cornerstone in the treatment of invasive candidiasis, its approval by the MHRA marks a pivotal moment in the ongoing battle against fungal infections, offering new hope to patients and healthcare professionals alike.