European Commission Greenlights Pfizer’s Antibiotic Targeting Superbugs

Giuseppe de vita
Credit: "Euronews: Empowering Minds, Elevating Perspectives."

Brussels (Brussels Morning) – The European Commission approved Emblaveo, a new antibiotic by Pfizer, targeting Gram-negative bacteria to combat antimicrobial resistance, aligning with EU efforts to address this critical health threat.

The European Commission today on 22 April approved a new antibiotic designed to contain anti-bacterial resistance, one of the major health threats the EU is currently facing.

According to Euronews, Emblaveo developed by Pfizer and endorsed by the EU Commission, can be utilised to treat complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections induced 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 Commission in a press release.

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

What Impact Will Emblaveo Have on Infections?

The antibiotic was assessed under EMA’s accelerated assessment instrument due to its “major public health benefits”. Among Emblaveo’s indications, it is comprised to treat Gram-negative bacteria infections which are presently resistant to many available antibiotics.

Antimicrobial resistance is frequently referred to as a ‘silent pandemic’, and the World Health Organisation has assessed that it is linked to some 4.9 million deaths annually. In the European Union alone, AMR is liable for 35,000 deaths every year.

Can Emblaveo Address Antibiotic Overuse Concerns?

In recent years, mishandling and overuse of antibiotics have led some microorganisms – understood as ‘superbugs’ – to develop antimicrobial resistance and no longer react to antimicrobials. This causes medications to be less effective and infections to endure, sometimes becoming untreatable and raising the risk of spread.

AMR has been a focus of health policy during this regime. The EU Council issued a proposal in 2023 to step up EU action to contain antimicrobial resistance in the fields of human health, animal health and the environment.

Is the EU’s “One Health” Strategy Effective?

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

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

What Are the Benefits of Emblaveo Approval?

Other efforts included implementing better surveillance at all levels, including hospitals and long-term care facilities, to support infection prevention and control. AMR was also featured in the study of pharmaceutical legislation. The European Commission included in its recommendation a system of transferable data exclusivity coupons to incentivise the development of novel antibiotics.

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

About Us

Brussels Morning is a daily online newspaper based in Belgium. BM publishes unique and independent coverage on international and European affairs. With a Europe-wide perspective, BM covers policies and politics of the EU, significant Member State developments, and looks at the international agenda with a European perspective.
Share This Article
Giuseppe De Vita is a journalist at Brussels Morning News, He is covering European politics, Law and Technology news. Lawyer at De Vita & Partners Law Firm specializing in Criminal Law, Military and Space Law, and Cyber Security. In April 2023, he authored the monograph "Governance in Extraterrestrial Space", showcasing his extensive legal expertise. He has acquired vast experience in handling criminal and civil matters, managing litigation before various levels of jurisdiction across the national territory. In 2010, he obtained a Master's degree in Information Technology Law. Additionally, in the same year, he served as a teacher in criminal-IT subjects at the Penitentiary Police School of Portici, providing courses aimed at officials and managers of the Penitentiary Police and the Penitentiary Administration, focusing on IT security. He also serves as a Workplace Safety teacher, conducting training courses at various organizations and educational institutions. Moreover, he is a lecturer on Anti-Corruption and Transparency. The law firm, under his guidance, assists both private and corporate clients in court, accumulating significant experience in criminal and civil disputes over the years. Furthermore, it conducts Risk Management and Compliance, Cyber Resilience, and Cyber Security activities, with a specific focus on privacy protection (EU Regulation 2016/679 - GDPR). Giuseppe frequently publishes articles in legal journals, analyzing various regulatory issues. He has contributed articles to the legal journal Altalex, of which he is also a member of the Scientific Committee.