Xediton Pharmaceuticals Inc. ("Xediton") Announced Today the Canadian Approval and Availability of Vabomere(r) (Meropenem-Vaborbactam) in Canada
Vabomere is indicated in adults for the treatment of complicated urinary tract infections including pyelonephritis, complicated intra-abdominal infection, hospital acquired pneumonia including ventilator associated pneumonia, bacteremia and other infections with limited treatment options known or suspected to be caused by susceptible microorganisms, including KPC-producing CRE—one of the most critical AMR threats identified by Health Canada and the World Health Organization.
'The launch of Vabomere® in Canada marks a significant milestone for our company, patients and healthcare practitioners,' said George Gafrey, President of Xediton Pharmaceuticals. This therapy provides physicians with a much-needed tool to treat life-threatening infections caused by organisms that are increasingly difficult to manage. We are proud of the collaborative effort by the Melinta and Xediton teams to make the product available, and we are committed to ensuring it reaches those who need it most.'
'We are thrilled that VABOMERE is now readily accessible to patients in Canada,' said Christine Ann Miller, President and Chief Executive Officer at Melinta. We are pleased to be able to partner with Xediton Pharmaceuticals in support of the registration and commercializing of VABOMERE in Canada, continuing to deliver on Melinta's commitment of ensuring that all people who need our life-saving therapies can get them.'
Vabomere combines meropenem, a trusted broad-spectrum carbapenem, with vaborbactam, a novel β-lactamase inhibitor.
The approval is supported by data from TANGO II, a global Phase III clinical trial demonstrating improved clinical cure rates and survival compared to best available therapy in patients with CRE infections.
Vabomere reflects Xediton Pharma's commitment to supporting antimicrobial stewardship and advancing therapies that protect patients and preserve the power of antibiotics.
About Vabomere®
VABOMERE is an antibacterial combination product for intravenous infusion containing meropenem (a trusted carbapenem) and vaborbactam (a novel beta-lactamase inhibitor). VABOMERE is indicated in adults for the treatment of the following infections known or suspected to be caused by carbapenem-resistant, vaborbactam/meropenem-susceptible Gram-negative bacteria:
Gram-negative organisms include Enterobacterales, such as Enterobacter cloacae, Escherichia coli, and Klebsiella pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
For further information on VABOMERE, please consult the product monograph available at: https://pdf.hres.ca/dpd_pm/00078122.PDF
About Xediton Pharmaceuticals Inc.
Xediton Pharmaceuticals is a specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. Xediton Pharmaceuticals is committed to developing, partnering and making available new and established medicines to promote the health of Canadians. Located in the Greater Toronto Area, Canada, Xediton Pharmaceuticals has products in Oncology, Anti-Infectives, Pain, CNS, GI, Ophthalmology, Renal and CV and has built strong strategic alliances with Global and International Healthcare and pharmaceutical companies.
For more information, please visit www.xediton.com
About Melinta Therapeutics
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. The company focuses its expanding portfolio on serving patients with an unmet need because that's how it makes the most meaningful impact. Melinta Therapeutics' 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, its commitment to patients, and its portfolio of therapies, including their important safety information, visit Melinta.com.
Contact:
George Gafrey, President of Xediton Pharmaceuticals Inc.
Email: [email protected]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/255443
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