Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults

Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).

The authorisation was based on positive results from the pivotal ReSTORE Phase III clinical
trial which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when
compared to the current standard of care, caspofungin, dosed once daily. These findings are supported by the STRIVE Phase II clinical trial and an extensive nonclinical development program.

ReSTORE, a multicentre, prospective, randomised and double-blind Phase III trial compared the efficacy and safety of intravenous rezafungin with intravenous caspofungin in eligible patients with invasive candidiasis. The primary efficacy outcome was global response (confirmed by the Data Review Committee [DRC]) at day 14.

Global response was determined from clinical response, mycological response, and radiologic response (for qualifying subjects with invasive candidiasis). Of the 187 patients in the modified intention-to-treat (mITT) population, 59.1% of patients in the rezafungin group (55/93) and 60.6% of patients in the caspofungin group (57/94) had a global response of cure at day 14 (weighted treatment difference −1.1% [95% CI −14.9, 12.7]). Non-inferiority was to be concluded if the lower bound of the 95% confidence internal (CI) for the difference in Day 14 cure rates (rezafungin – caspofungin) was >-20%.

Rezafungin was generally well tolerated in clinical trials, to date very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea. Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash. Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.

Uncommon adverse events were hyperphosphataemia, hyponatraemia, phototoxicity, tremor and increased eosinophil count. There were spontaneous reports of urticaria (frequency not known). Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.

Rezafungin may cause increased risk of phototoxicity. Eligible patients should be advised to
avoid sun exposure and other sources of UV radiation without adequate protection during
treatment and for 7 days after the last administration of rezafungin.

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or
deep/visceral tissues. It affects seriously ill people, especially those with a weakened
immune system and the mortality rate can be 40% or more. It can place a large burden on
the healthcare system, with the potential for extended treatment regimens and long hospital stays. In the last 15 years there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options.

Professor P. Lewis White PhD, FECMM, FRCPath, Consultant Clinical Scientist and Head of
the PHW Mycology Reference Laboratory, Honorary Professor, Cardiff University Centre for
Trials Research said: “Invasive candidiasis remains a difficult-to-treat disease which has a
significant impact on critically ill and immunocompromised patients. With limited advances in treating this condition over the past 15 years, today’s announcement is a positive step towards supporting eligible patients and could enable the healthcare professional community an alternative way to manage these patients with invasive candidiasis using a new, once-weekly intravenous treatment option.”

“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,” said Dr Ben David, Medical Director for Northern Europe at Mundipharma.

Rezafungin has been granted Orphan Drug Designation (ODD) in GB for the treatment of
invasive candidiasis in adults. The MHRA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 5 in 10,000 people in GB where no satisfactory method of diagnosis, prevention or treatment of the condition concerned exists, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

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