Napp Secures Approval for REZZAYO® from the UK Medicines and Healthcare Products Regulatory Agency for Treating Invasive Candidiasis in Adults.

For Exclusive Distribution to GB Trade and Medical Media

REZZAYO® (rezafungin) is approved for treating invasive candidiasis in adults. Adherence to official guidelines regarding the appropriate use of antifungal agents is recommended.2 The marketing authorization stems from favorable outcomes in the pivotal ReSTORE Phase III clinical trial, backed by findings from the STRIVE Phase II clinical trial and an extensive nonclinical development program.3,4 This marks a significant milestone as the first new treatment option in over 15 years for eligible adult patients with invasive candidiasis, and Napp Pharmaceuticals Limited (Napp) will be the supplier in GB.5-9

Napp Pharmaceuticals Limited, part of the global network of independent associated companies under Mundipharma, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the use of rezafungin in treating invasive candidiasis in adults in Great Britain (GB). This milestone reflects our dedication to providing an additional therapeutic option for eligible adult patients grappling with invasive candidiasis.

The authorization is founded on positive outcomes from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, administered once weekly, compared to the current standard of care, caspofungin, administered once daily. These results are corroborated by findings from the STRIVE Phase II clinical trial and an extensive nonclinical development program.

The ReSTORE trial, a multicenter, prospective, randomized, and double-blind Phase III study, compared the efficacy and safety of intravenous rezafungin with intravenous caspofungin in eligible patients with invasive candidiasis. The primary efficacy outcome was the global response (confirmed by the Data Review Committee [DRC]) at day 14, determined from clinical, mycological, and radiologic responses for qualifying subjects. In the modified intention-to-treat (mITT) population, 59.1% of patients in the rezafungin group and 60.6% in the caspofungin group achieved a cure at day 14, with a weighted treatment difference of −1.1% [95% CI −14.9, 12.7]. Non-inferiority was established with the lower bound of the 95% confidence interval for the difference in Day 14 cure rates being >-20%.

Rezafungin demonstrated overall good tolerability in clinical trials, with common adverse reactions including hypokalaemia, pyrexia, and diarrhea. Uncommon adverse events such as hyperphosphataemia, hyponatraemia, phototoxicity, tremor, and increased eosinophil count were reported. Notably, eligible patients should be cautioned about an increased risk of phototoxicity, advising them to avoid sun exposure and other UV radiation sources during treatment and for 7 days after the last administration of rezafungin.

Invasive candidiasis poses a severe, life-threatening infection affecting critically ill individuals, especially those with weakened immune systems, with mortality rates exceeding 40%. The healthcare system bears a substantial burden due to extended treatment regimens and prolonged hospital stays. The approval of rezafungin marks a significant advancement, offering a new, once-weekly intravenous treatment option for eligible patients with invasive candidiasis.

Professor P. Lewis White, a Consultant Clinical Scientist, emphasized the impact of invasive candidiasis on critically ill and immunocompromised patients, acknowledging the positive step forward in patient support with this new treatment option. Dr. Ben David, Medical Director for Northern Europe at Mundipharma, highlighted the authorization as a result of years of commitment to developing additional therapeutic options for infectious diseases.

Rezafungin has been granted Orphan Drug Designation (ODD) in GB for treating invasive candidiasis in adults by the MHRA, underscoring its significance for rare diseases affecting fewer than 5 in 10,000 people where no satisfactory method of diagnosis, prevention, or treatment exists, or the medicine provides significant benefits to those affected.

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