New medicine to treat infections in adults
Vabomere, a combination of an antibiotic and new beta-lactamase inhibitor, addresses bacterial resistance
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults:
- Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them;
- Complicated intra-abdominal infection;
- Hospital-acquired pneumonia, including ventilator associated pneumonia;
- Bacteria in the blood associated with any of the infections listed above;
- Infections due to aerobic Gram-negative organisms in adults with limited treatment options.
The lack of availability of medicines to treat patients with infections caused by resistant bacteria has become a major problem in recent years. It is estimated that at least 25,000 patients in the European Union (EU) die each year from infections due to bacteria that are resistant to many medicines.
Vabomere is a fixed combination of vaborbactam, a new beta-lactamase inhibitor and meropenem, a broad-spectrum antibiotic belonging to the class of carbapenems that is already approved for use in the EU. It is a powder for concentrate for solution for infusion (drip into a vein).
Resistance to carbapenems has been increasing lately, in particular in Gram-negative bacteria, and is of major concern. Beta-lactamases are enzymes involved in bacterial resistance to these antibiotics. By inhibiting the action of beta-lactamases, vaborbactam protects meropenem from being inactivated and restores its activity against many, but not all, carbapenem-resistant pathogens.
In the clinical development program, the exposure to vaborbactam at the recommended dose was shown to be sufficient to protect the activity of meropenem against carbapenem-resistant Enterobacteriaceae. The CHMP also agreed that the studies did not indicate any major concerns regarding the safety profile of meropenem-vaborbactam.
EMA contributes to the European and global effort to tackle antimicrobial resistance. A major area of activity is to create an environment that stimulates and facilitates the development of new antimicrobials. The Agency’s activities also include the monitoring and analysis of data on antimicrobials to guide policy and research, as well as the promotion of their responsible use.
The opinion adopted by the CHMP is an intermediary step on Vabomere’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisations has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.
- The applicant for is Rempex London Ltd.
|New medicine to treat infections in adults||(English only)||21/09/2018|
Latest News from
European Roma Holocaust Memorial Day: Statement by President von der Leyen, Vice-President Jourová and Commissioner Dalli30/07/2021 13:25:00
European Roma Holocaust Memorial Day: Statement given by President von der Leyen, Vice-President Jourová and Commissioner Dalli.
Global Education Summit: Team Europe pledges leading contribution of €1.7 billion to the Global Partnership for Education30/07/2021 11:33:00
At yesterday's Global Education Summit in London, the European Union and its Member States, as Team Europe, pledged €1.7 billion to the Global Partnership for Education (GPE) to help transform education systems for more than one billion girls and boys in up to 90 countries and territories.
EU Cohesion policy: Commission adopts €21 billion Greek Partnership Agreement for 2021-202730/07/2021 09:25:00
The Commission has adopted the first Partnership Agreement for the 2021-2027 programming period for Greece, the first EU country to submit its strategic reference document for deploying more than €21 billion of investments for its economic, social and territorial cohesion.
Commission adopts new guidance on how to climate-proof future infrastructure projects29/07/2021 15:25:00
Today, the European Commission has published new technical guidance on climate-proofing of infrastructure projects for the period 2021-2027.
Mergers: Commission approves acquisition of Telekom Romania by Orange, subject to conditions29/07/2021 13:25:00
The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of Telekom Romania Communications (“TKR”) by Orange SA (“Orange”).
Delta AM completes first €75 million closing of its SME senior secured fund with EU support29/07/2021 12:43:00
Delta AM, an alternative asset manager that is part of Groupe Burrus (via Dôm Finance), has completed the first closing of its senior secured fund, France Économie Réelle (FER), raising around €75 million from the European Investment Fund (EIF), backed by the Investment Plan for Europe, an anchor investor alongside Groupe Burrus and nine other key institutional investors.
EU invests €122 million in innovative projects to decarbonise the economy28/07/2021 09:25:00
For the first time since the creation of the Innovation Fund, the European Union is investing €118 million into 32 small innovative projects located in 14 EU Member States, Iceland and Norway.
Statement by President von der Leyen on a new milestone in the EU Vaccines Strategy27/07/2021 15:25:00
Statement given by President von der Leyen on a new milestone in the EU Vaccines Strategy.
Commission opens infringement procedures against 12 Member States for not transposing EU rules banning unfair trading practices27/07/2021 13:25:00
The Commission opened infringement procedures against 12 Member States for failing to transpose EU rules banning unfair trading practices in the agri-food sector.