Mundipharma announces European approval of REZZAYO® (rezafungin) for the treatment of Invasive Candidiasis in adults

2023-12-22

临床3期临床结果上市批准孤儿药临床2期

CAMBRIDGE, England--(BUSINESS WIRE)--Mundipharma today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

'There has been a significant global unmet need for treating people with invasive candidiasis. Today\u2019s announcement by the European Commission<sup> </sup>marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.'

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 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.1,2,4 These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.1,2

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.5,6 It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more.7,8 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.9 Over 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.3,10

Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “There has been a significant global unmet need for treating people with invasive candidiasis. Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.”

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

Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU.11

*To meet the pre-specified limit of non-inferiority, 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 pre-specified 20% limit, establishing non-inferiority.1

About invasive candidiasis

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. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.8,9 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.12

About Mundipharma

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

Mundipharma 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. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information, visit www.mundipharma.com.

REZZAYO® is a registered trademark of Cidara Therapeutics, Inc., used under license by Mundipharma.

References:

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

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 at ECCMID 2022.

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

Committee for Medicinal Products for Human Use Opinion. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed December 2023).

Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026.

CDC. Invasive candidiasis. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/fungal/diseases/candidiasis/invasive/definition.html (last accessed December 2023).

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

Bassetti M, et al. Crit Care 2019;23(1):219.

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

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

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).

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