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     233  0 Kommentare Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO - Seite 2

    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.

    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 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.

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