Mundipharma announces European approval of REZZAYO (rezafungin) for the treatment of invasive candidiasis in adults

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For specialist and medical media only

  • The approval is based on the positive results of the pivotal Phase III ReSTORE clinical trial and is supported by STRIVE’s Phase II clinical trials and an extensive non-clinical development program.1.2
  • Rezafungin represents the first new treatment option for patients with invasive candidiasis in over 15 years.3

Mundipharma today announced that Rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasiswas approved for adults.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on the results of the pivotal phase III clinical trial ReSTORE, which demonstrated statistical non-inferiority* of rezafungin administered once weekly Compared to the current standard of care caspofungin, which is administered once daily.1,2,4 These results are supported by positive results from the Phase II STRIVE clinical trial and an extensive non-clinical development program.1.2

Invasive candidiasisis a serious, life-threatening infection of the bloodstream and/or deep/visceral tissue.5.6 It affects seriously ill people, particularly those with weakened immune systems, and the mortality rate can be 40 or more.7.8 It can place a major burden on the healthcare system, with the potential for extensive treatments and long hospital stays.9 Over the past 15 years, there have been no new treatments and morbidity and mortality rates have remained largely the same, indicating the need for alternative treatment options.3.10

Professor Oliver Cornely, Head of the European Center of Excellence for Medical Mycology at the University Hospital of Cologne and member of the data review committee of the phase III ReSTORE study, said: “There is a significant unmet need worldwide for the treatment of people with invasive candidiasis. Today’s announcement from the European Commissionmarks an important moment that could allow the medical community to treat invasive candidiasis patients differently with a new treatment option.”

“European approval“is the culmination of years of developing an additional treatment option for patients with invasive candidiasis and underscores our commitment to supporting the treatment of infectious diseases,” said Yuri Martina, Chief Development and Medical Officer at Mundipharma.

Rezafungin has received orphan drug designation in the EU for the treatment of invasive candidiasis.11

*To achieve the prespecified non-inferiority limit, the upper (for all-cause mortality) and lower (for global cure) 95% confidence limits for the difference between arms must be within 20. Both endpoints met the prespecified 20 % limit and thus demonstrated non-inferiority.1

About invasive candidiasis

Invasive candidiasis (IC) remains an area of ​​significant unmet need, particularly in critically ill hospitalized patients and those with compromised immune systems. Despite a range of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.8.9 IC is a severe, life-threatening systemic condition Candida-Infection of the bloodstream and/or deep/visceral tissue known as candidemia and deep tissue candidiasis.12

About Mundipharma

Mundipharma is a global healthcare company with a presence in Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East.

Mundipharma’s mission is to provide patients with innovative treatments in the areas of pain management, infectious diseases and consumer health, as well as other areas of serious and debilitating diseases. Her guiding principles, centered around integrity and patient-centeredness, are at the heart of everything she does. For more information please visit www.mundipharma.com.

REZZAYOis a registered trademark of Cidara Therapeutics, Inc. and is used under license from Mundipharma.

Sources:

  1. Thompson GR, et al. Lancet 2023;401(10370):49-59.
  2. Soriano A, et al, Patient-level Meta-Analysis of Efficacy and Safety from STRIVE and ReSTORE: Randomized, Double-blinded, Multicenter Phase 2 and Phase 3 Trials of Rezafungin in the Treatment of candidemia and/or invasive candidiasis, abstract presented on the ECCMID 2022.
  3. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14-i25 doi:10.1093/jac/dkx445
  4. Statement of the Committee for Medicinal Products for Human Use. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed December 2023).
  5. Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026.
  6. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed December 2023).
  7. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445-56.
  8. Bassetti M, et al. Crit Care 2019;23(1):219.
  9. Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920.
  10. Ham YY, et al. Future Microbiology 2021;16(1):27-36.
  11. European Commission. Community Register of Orphan Medicinal Products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm (last accessed December 2023).
  12. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and risk factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed December 2023).

SciA-RZF-2300041

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Contacts:

Liana Del Medico

[email protected]

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