Melinta Therapeutics Announces Commercial Availability of REZZAYO™ (rezafungin for injection)
31 Jul 2023
Drug ApprovalPriority Review
New Treatment for Candidemia and Invasive Candidiasis Now Available in the U.S.
PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.
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While echinocandins have been available since the early 2000’s, their use has been primarily limited to the hospital in-patient setting due to their requirement of daily IV infusions. In contrast, REZZAYO is administered as a once weekly infusion, creating the opportunity for appropriate patients to leave the hospital sooner to continue their treatment at home, potentially reducing the burden on patients and the healthcare system.
John Harlow, Chief Commercial Officer for Melinta Therapeutics said, “Making REZZAYO available in the U.S. is another way Melinta will leverage our expansive commercial infrastructure and experience launching products and therapies into acute care environments with the ultimate goal of better patient care and outcomes.”
Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics. Once-weekly REZZAYO is available by prescription beginning July 31, 2023.
Harlow added, “The availability of REZZAYO, the first new treatment of its kind in over a decade, is a major step forward in offering healthcare providers a way to simplify and treat patients suffering from invasive Candida infections. It’s a much-needed option for physicians, and those patients who may be able to transition out of the hospital sooner.”
About REZZAYO™ (rezafungin for injection)
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
Contraindications
REZZAYO™ is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
Warnings and Precautions
Infusion-related Reactions: 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.
Photosensitivity: REZZAYO™ may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Hepatic Adverse Reactions: 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.
Adverse Reactions
Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see full Prescribing Information for REZZAYO™ (rezafungin for injection), available at .
About Melinta Therapeutics
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit Melinta.com.
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