- The
UK MHRA approval follows approvals by theU.S. FDA and theEuropean Commission - Cidara is entitled to receive a milestone payment of approximately
$2.8 million fromMundipharma
“Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said
This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the
About
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 and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the
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 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.
About REZZAYO® (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in
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.
Forward-Looking Statements
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, and the likelihood that rezafungin will be prescribed by physicians in the
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Source:
2024 GlobeNewswire, Inc., source