预约演示

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 adults1

2024-02-02

临床3期临床结果孤儿药上市批准

'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'

CAMBRIDGE, England--(BUSINESS WIRE)--Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent asinvasive candidiasistoday announced that the Medicines and Healthcare Products Rinfectious diseasesHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

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.2,3,4 These findings are supported by the STRIVE Phase II clinical trial and an extensive nonclinical development program.3,4

ReSTORE, a multicentre, prospective, Napp Pharmaceuticals LimitedPhase III trial compared the efficacy and sMundipharmatravenous rezafungin with intravenous caspofungin in eligiblMedicines and Healthcare Products Regulatory Agency (MHRA)acy outcome was rezafunginponse (confirmed by thinvasive candidiasistee [DRC]) at day 14.3 Global response was determined from clinical response, mycological response, and radiologic response (for qualifying subjects with invasive candidiasis).2,3 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].2,3 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%.2

Rezafungin was generally well tolerated in clinical trials, to date very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea. Commorezafunginreactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotcaspofunginezing, 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.2

Rezafungin may cause increased risk of phototoxicity. Eligible patients should be advised to avoid sun exposure and other sourcesrezafunginiation without adecaspofunginction during treatment and invasive candidiasis.2,3t administration of rezafungin.2invasive candidiasis).2,3 rezafungin caspofungin rezafungin caspofungin

Rezafunginandidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tisshypokalaemia apyrexiaserioudiarrhoeaeople, especially those with a weakanaemiamuhypomagnesaemiahehypophosphataemiaanhypotensionmore.12,13 Ivomitingacnauseargabdominal paine constipationyserythemah the rashntial for extendedalkaline phosphataseanhepatic enzymes stays.14 In the last 15 years there have been no new treatments and morbidity and mortality rates remain largely the samehyperphosphataemiaeehyponatraemiatiphototoxicityoptremor5-9,15urticaria rezafungin nausea

RezafunginP. 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 difficultrezafungin.2sease 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.”

Invasive candidiasisis a culmination of years of devinfectionn 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.1 The MHRA grants ODD to medicines intended for the treatment, diagnosis or preventInvasive candidiasis 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.16invasive candidiasis

*ENDS*invasive candidiasis infectious diseases

Rezafunginsive candidiasisinvasive candidiasis MHRA

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems.14 Despite a number of available treatments, the mortality rate for patients with invasive candidiasis can be 40% or more.13,14 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.17

About invasive candidiasis

Invasive candidiasis (IC)e-weekly echinocandin that has been developed for the treatment of invasive candidiasis in adults.18invasive candidiasis IC systemic Candida infection

About Rezafungin

Rezafunginaceuticals Limited is paechinocandinharma, a global healthcare company with a presinvasive candidiasisAsia Pacific, Canada, Europe, Latin America, and the Middle East.

MundipNappa is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com

Napp Pharmaceuticals Limited Mundipharma

A second Phase III clinical trial of rezafungin for the prevention of invasive fungal dpainse in patientinfectious diseaseeneic blood and marrow transplantation (ReSPECT trial) is currently being conducted.18

Registered office addresses

NAPP PHARMACEUTICALS LIMITED a companrezafungints registered office atinvasive fungal disease, Milton Road, Cambridge CB4 0AB, England.

MUNDIPHARMA RESEARCH LIMITED, a company having its registered office at Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, England.

NAPP PHARMACEUTICALStered Trademark of Cidara Therapeutics, Inc, used under license.

MUNDIPHARMA RESEARCH LIMITED

1.REZZAYOicines and Healthcare ProductsCidara Therapeutics, Incrisation. Available at: https://www.gov.uk/government/news/rezzayo-approved-to-treat-adult-patients-with-invasive-candidiasis (last accessed February 2024)

2. REZZAYO® Summary of Product Characteristics.

3. Thompson GR, et al. Lancet 2023;401(10370):49–59.

4. REZZAYOn GR, et al. Lancet Infect Dis 2023; https://doi.org/10.1016/S1473-3099(23)00551-0

5. Ham YY, et al. Future Microbiology 2021;16(1):27–36.

6. CANCIDAS (formerly Caspofungin MSD) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/cancidas-previously-caspofungin-msd (last accessed February 2024).

7. Vfend (voriconazole) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/vfend (last accessed February 2024).

8. CANCIDASanidulafungCaspofunginvailable at: https://www.ema.europa.eu/en/medicines/human/EPAR/ecalta (last accessed February 2024).

9. Mycamine (micafungin) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/mycamine (last accessed February 2024).

10.Ecalta anidulafungint Rev Dis Primers 2018;4:18026.

11. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed February 2024).

12. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56.

13. BasseInvasive candidiasisare 2019;23(1):219.

14. Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920.

15. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445.

16. UK Medicines and Healthcare Products Regulatory Agency, Guidance – Orphan medicinal products. Available at: https://www.gov.uk/guidance/orphan-medicinal-products-in-great-britain (last accessed February 2024).

17. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed February 2024).

18. Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of invasive candidiasis. Available at https://www.mundipharma.com/Cidara-Therapeutics-and-Mundipharma-Announce-Positive-Topline-Results-from-the-Global-Phase-3-Pivotal-ReSTORE-Trial-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis (last accessed February 2024).

Job code: UK-RZF-2300053Invasive candidiasis

DateCidara TherapeuticsbruarMundipharma Rezafungin invasive candidiasis