Rezafungin Awarded Promising Innovation Medicine (PIM) Designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the Treatment of Invasive Candidiasis
For Trade and Medical Media Only
- Rezafungin is a next-generation once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia.
- Despite currently available treatments, the mortality rate for patients with invasive candidiasis is up to 40%.1
Promising Innovation Medicine designation is an early indication that rezafungin may be eligible for the Early Access to Medicines Scheme in the
UKwhich permits the use of medicines not yet approved by the relevant regulatory authorities.
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For the MHRA to grant a PIM designation, medicinal products must meet the following criteria:2
- The condition should be life-threatening or seriously debilitating with a high unmet need for which there is no method of treatment, diagnosis or prevention available or where existing methods have serious limitations.
The medicinal product is likely to offer major advantage over methods currently used in the
- The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
A PIM designation is a pre-requisite for application to the UK’s Early Access to Medicines Scheme (EAMS). This scheme aims to give patients with life threatening or seriously debilitating conditions such as invasive candidiasis, access to medicines that do not yet have a marketing authorisation.
“This PIM designation for once-weekly rezafungin is indicative of the potential that this product may have in helping patients to fight deadly Candida infections,” said
Cidara has partnered with
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%.1 IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.3
Rezafungin is a next-generation once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).4
In this ReSTORE trial, rezafungin met the primary endpoint for the
Cidara is also currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).
Rezafungin has been designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin; whether rezafungin will be approved for marketing in the
- Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015; 373:1445-1456.
PIM designation guidance. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375327/PIM_designation_guidance.pdf (last accessed
Cortes JA, Corrales IF. Invasive Candidiasis: Epidemiology and Risk Factors.
November 2018. Available at https://www.intechopen.com/chapters/64365. Last accessed February 2022.
Cidara Therapeuticsand Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and 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 2022.
U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey= 507215. Last accessed February 2022
European Commission. Community Registerof orphan medicinal products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm. Last accessed February 2022.
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