Antimicrobial resistance: Commission authorizes a new antibiotic

Today, following a recommendation from the European Medicines Agency, the Commission has adopted the authorisation of a new antibiotic, Emblaveo, which 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. It is estimated that 35,000 deaths in the EU are caused by drug-resistant bacteria every year. This new antibiotic, the sixth to be authorized in the EU since 2020, will help treat infections from aerobic Gram-negative bacteria, which are resistant to many of the currently available antibiotics. It will therefore contribute to tackling the serious problem of antimicrobial resistance and provide patients with treatment options where currently there are few or none.  Given the major public health benefits of this new antibiotic, it was evaluated under EMA's accelerated assessment mechanism.

The development of Emblaveo was supported by the Innovative Medicines Initiative COMBACTE-CARE project, which was co-funded by the EU and the pharmaceutical industry. Two of the Emblaveo clinical studies were backed by COMBACTE-CARE and the important results stemming from the project show the benefits of a collaborative approach of public and private partners.

More information

Antimicrobial drug resistance (AMR)

Innovative Health Initiative