Recommended to be approved for treatment of:
- 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 –
- Infections due to aerobic Gram-negative organisms where treatment options are limited-
NEW HAVEN, CT, USA I September 21, 2018 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vabomere™ (meropenem and vaborbactam) for approval as a treatment for 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.
The CHMP’s opinion will be reviewed by the European Commission (EC), which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere’s European approval would not take effect until marketing authorization is granted by the EC.
“We are encouraged by the CHMP’s positive recommendation for Vabomere, which brings us one step closer to providing access to this important treatment option for patients in Europe,” said Dan Wechsler, President and CEO of Melinta. “Additionally, we were pleased to see the range of indications recommended for approval, underscoring our belief that Vabomere represents a significant new advancement in addressing the increasing incidence of KPC-producing Enterobacteriaceae, for which there are currently limited treatment options.”
The CHMP opinion was supported by data from the TANGO clinical program, including data from TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults, as well as TANGO-2, a multi-center, randomized, open-label clinical trial of Vabomere versus “best available therapy” in subjects with known or suspected carbapenem-resistant Enterobacteriaceae (CRE).
Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients who have been diagnosed with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by treatment of adult patients caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which is a new class of beta-lactamase inhibitor that inhibits certain types of resistance mechanisms used by bacteria.
About VABOMERE™ (meropenem and vaborbactam) for Injection
VABOMERE (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
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.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela™ (delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
SOURCE: Melinta Therapeutics
Post Views: 120
Recommended to be approved for treatment of:
- 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 –
- Infections due to aerobic Gram-negative organisms where treatment options are limited-
NEW HAVEN, CT, USA I September 21, 2018 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vabomere™ (meropenem and vaborbactam) for approval as a treatment for 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.
The CHMP’s opinion will be reviewed by the European Commission (EC), which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere’s European approval would not take effect until marketing authorization is granted by the EC.
“We are encouraged by the CHMP’s positive recommendation for Vabomere, which brings us one step closer to providing access to this important treatment option for patients in Europe,” said Dan Wechsler, President and CEO of Melinta. “Additionally, we were pleased to see the range of indications recommended for approval, underscoring our belief that Vabomere represents a significant new advancement in addressing the increasing incidence of KPC-producing Enterobacteriaceae, for which there are currently limited treatment options.”
The CHMP opinion was supported by data from the TANGO clinical program, including data from TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults, as well as TANGO-2, a multi-center, randomized, open-label clinical trial of Vabomere versus “best available therapy” in subjects with known or suspected carbapenem-resistant Enterobacteriaceae (CRE).
Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients who have been diagnosed with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by treatment of adult patients caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which is a new class of beta-lactamase inhibitor that inhibits certain types of resistance mechanisms used by bacteria.
About VABOMERE™ (meropenem and vaborbactam) for Injection
VABOMERE (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
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.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela™ (delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
SOURCE: Melinta Therapeutics
Post Views: 120
