Announces REZZAYO® Approval in Spain for Invasive Candidiasis Treatment by Mundipharma
Mundipharma announces today that Spain’s Ministry of Health has approved reimbursement for REZZAYO® (rezafungin acetate) as a treatment for invasive candidiasis in adults. This announcement follows the European Commission’s endorsement of REZZAYO® based on successful results from the pivotal Phase III ReSTORE clinical trial. The trial demonstrated that weekly dosing of rezafungin was non-inferior to daily doses of the current standard of care, caspofungin. The Phase II STRIVE clinical trial and extensive non-clinical studies further support these positive results, reinforcing the company’s commitment to advancing treatment options.
Juan Vergez, General Manager of Mundipharma Spain, announces, “The reimbursement and availability of REZZAYO® in Spain represents a significant advancement in addressing the complex and evolving landscape of fungal infections for patients and healthcare professionals.” This announcement marks a pivotal moment in addressing a critical medical challenge that affects individuals with compromised immune systems.
Invasive candidiasis is a serious and potentially life-threatening infection that affects the bloodstream and internal organs, particularly in immunocompromised individuals. With mortality rates often exceeding 40%, the infection places a heavy burden on the healthcare system, requiring long hospital stays and extended treatments. Despite significant advances in medicine, the treatment landscape for invasive candidiasis has remained stagnant over the past 15 years. This underscores the urgent need for new therapies, and Mundipharma announces REZZAYO® as an innovative solution.
Dr. Patricia Muñoz, Head of Infectious Diseases and Clinical Microbiology at Gregorio Marañón Hospital in Madrid, also announces, “The approval of REZZAYO® represents a major step forward in the treatment of invasive candidiasis, offering an effective new treatment option.” She explains that in her clinical experience, particularly with critically ill and immunosuppressed patients, the weekly dosing regimen could simplify treatment and improve patient adherence, ultimately enhancing outcomes for a life-threatening infection.
Mundipharma’s ongoing commitment to advancing treatments for infectious diseases is underscored by Dr. Yuri Martina, Chief Development and Medical Officer, who announces, “This approval highlights years of development of a novel treatment for invasive candidiasis and demonstrates our ongoing commitment to addressing the global challenge of infectious diseases.”
Dr. Tatiana Vilchez, Senior Medical Director at Mundipharma Spain, further announces, “The approval of REZZAYO® offers a breakthrough in clinical practice, providing a patient-centered therapeutic option to address the critical need in managing invasive candidiasis.” This announcement signals a new era in treatment, aligning with the company’s dedication to offering evidence-based solutions that enhance patient outcomes.
Rezafungin, an innovative first-generation echinocandin, was initially approved by the U.S. Food and Drug Administration (FDA) in March 2023 for treating candidemia and invasive candidiasis, especially for those with limited treatment options. Following that approval, the European Commission authorized it in December 2023 for treating invasive candidiasis in adults. Mundipharma announces that rezafungin is now available in the U.S., the United Arab Emirates, the U.K., Germany, and Spain. Additional marketing applications for other geographies are also under review.
About Invasive Candidiasis
Invasive candidiasis (IC) remains a significant medical challenge, particularly for hospitalized patients and those with weakened immune systems. Despite the availability of several treatments, mortality rates for IC can still exceed 40%. Candidemia, when it affects the bloodstream, is a life-threatening infection that requires immediate and effective treatment.
About Rezafungin
Rezafungin is a new-generation echinocandin with a differentiated pharmacokinetic/pharmacodynamic (PK/PD) profile designed specifically for treating invasive candidiasis in adults. In the ReSTORE clinical trial, rezafungin met primary clinical endpoints, showing non-inferiority to daily caspofungin in reducing all-cause mortality at Day 30 and achieving overall cure by Day 14. Rezafungin was well-tolerated and demonstrated a safety profile comparable to caspofungin.
Mundipharma is currently conducting a Phase II clinical trial of rezafungin for the prevention of invasive fungal disease in adult recipients of allogeneic blood and marrow transplantation (ReSPECT trial).
About Mundipharma
Mundipharma is a global healthcare company serving patients in regions such as Africa, Asia Pacific, Europe, Latin America, and the Middle East. With a strong focus on providing innovative treatments in areas like pain management and infectious diseases, Mundipharma announces its continued dedication to integrity and patient-centered care in all its initiatives, ensuring that every step is taken with the patient’s needs at the heart of everything they do.
Please find the related post
