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EU Policy. Commission approves superbug-busting antibiotic

The European Commission has authorised a new antibiotic aimed to fight anti-bacterial resistance.
The European Commission has authorised a new antibiotic aimed to fight anti-bacterial resistance. Copyright Julio Cortez/Copyright 2018 The AP. All rights reserved.
Copyright Julio Cortez/Copyright 2018 The AP. All rights reserved.
By Marta Iraola Iribarren
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The European Commission today (22 April) authorised a new antibiotic designed to counter anti-bacterial resistance, one of the biggest health threats the EU is currently facing.

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Emblaveo, developed by Pfizer and approved today by the European Commission, can be used to treat complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of drug-resistant bacteria.

“This newly approved medicine will fill an important gap where there are currently a very limited number of treatment options,” said the EU executive in a press release.

This authorisation comes a month after the European Medicines Agency adopted a positive opinion and recommended its marketing authorisation.

The antibiotic was evaluated under EMA’s accelerated assessment mechanism due to its “major public health benefits”.

Among Emblaveo’s indications, it is included to treat Gram-negative bacteria infections which are currently resistant to many available antibiotics.

Antimicrobial resistance is often referred to as a ‘silent pandemic’, and the World Health Organisation (WHO) has estimated that it is associated with some 4.9 million deaths annually. In the EU alone, AMR is responsible for 35,000 deaths every year.

In recent years, misuse and overuse of antibiotics have led some microorganisms - known as ‘superbugs’ - to develop antimicrobial resistance and no longer respond to antimicrobials. This causes medicines to be less effective and infections to persist, sometimes becoming untreatable and increasing the risk of spread.

EU action against antimicrobial resistance

AMR has been a priority for health policy during this mandate. The European Council issued a recommendation in 2023 to step up EU action to combat antimicrobial resistance in the fields of human health, animal health and the environment.

The EU strategy is a “One Health” approach, recognising that human and animal health and the environment are linked and that the fight against AMR needs a coordinated effort in these three areas.

The Council’s recommendation set out concrete targets at EU level for antimicrobial consumption and resistance in human health, including a 20% reduction in total human consumption of antibiotics by 2030.

Other measures included implementing better surveillance at all levels, including hospitals and long-term care facilities, to strengthen infection prevention and control.

AMR also featured in the review of the pharmaceutical legislation. The European Commission included in its proposal a system of transferable data exclusivity vouchers to incentivise the development of novel antibiotics.

The voucher would grant an additional year of regulatory data protection to developers, which they can use for one of their products or sell to another marketing authorisation holder.

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