World News: 13:00 GMT Tuesday 27th November 2018. [Melinta Therapeutics via Globe Newswire via SPi World News]
NEW HAVEN, Conn., Nov. 27, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that the European Commission (EC) has approved Vabomere (meropenem and vaborbactam) for use in adult patients with complicated intra-abdominal (cIAI) and urinary tract infections (cUTI), hospital-acquired pneumonia including ventilator associated pneumonia (HAP/VAP), bacteraemia that occurs in association with any of these infections, and infections due to aerobic gram-negative organisms where treatment options are limited. Marketing authorization was granted in all 28 European Union (EU) member states, as well as Norway, Iceland and Liechtenstein.
“Few effective treatment options and increasing resistance have made KPC-producing Enterobacteriaceae a significant challenge to patients worldwide,” said John H. Johnson, Interim CEO and Director of Melinta. “With the EC authorization of Vabomere, we believe Melinta, through its strong partnership with Menarini Group, will be able to make a significant impact on the European effort to address this life-threatening pathogen."
The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2018, that was based in part on data from the TANGO clinical program.
TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study, evaluated the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of adults with cUTI, including acute pyelonephritis. TANGO-2, a multi-center, randomized, open-label clinical trial, assessed VABOMERE versus “best available therapy” in adults with known or suspected carbapenem-resistant Enterobacteriaceae (CRE).
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 or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.
Warnings and Precautions
Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.
Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE is necessary, consider supplemental anticonvulsant therapy.
In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of non-susceptible organisms.
The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.
Please see for the full US FDA-approved prescribing information.
Globe Newswire: 13:00 GMT Tuesday 27th November 2018
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