- Approval based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.
- REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.
- Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
SAN DIEGO, Dec. 22, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in 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 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. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.
Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. 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.
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.“
Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara, said, “We welcome the European approval, which makes this treatment option available to patients in Europe alongside patients in the United States following the FDA’s approval earlier this year. This is a great step forward on our journey to help patients with serious Candida infections across the globe.“
Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU.
Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.
Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union (EU) approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma. Under the licensing agreement, Cidara remains eligible to receive additional potential payments of up to approximately $470 million upon achievement of development and regulatory milestones planned over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales.
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%. 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.
About REZZAYO® (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.
INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.
Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.
About Cidara Therapeutics
Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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 harbour 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, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.