Green light from the European Commission for the marketing of emblaveo (aztreonam/avibactam). A new antibiotic developed by Pfizer to treat complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of drug-resistant bacteria. The authorization follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last March. The EMA’s decision was taken following an accelerated evaluation mechanism given the urgency and need for new antibiotics especially against resistant bacteria.
The problem of antibiotic resistance
It is estimated that 35,000 deaths in the EU are caused by drug-resistant bacteria every year. This new antibiotic, the sixth authorized in the EU since 2020, will help treat infections caused by aerobic Gram-negative bacteria, which are resistant to many of the antibiotics currently available. It will therefore help address the serious problem of antimicrobial resistance and provide patients with treatment options where there are currently few or none.
The synergy between avibactam and aztreonam
The new drug (to be administered intravenously) provides a synergy between the two molecules: avibactam, an inhibitor of beta-lactamases which prevents some of them (class A, class C and some classes D) from hydrolysing aztreonam. The latter is a beta-lactam capable of inhibiting the synthesis of the bacterial cell wall by targeting penicillin-binding proteins (Pbp), thus being effective even against bacteria that have become resistant. Aztreonam is already authorized for exclusive use in European Union countries, while avibactam is used in combination with ceftazidime.
Clinical studies on emblaveo
Clinical studies have shown that si emblaveo is effective in treating infections for which aztreonam is already used, as well as infections due to aerobic Gram-negative organisms. Microbiological data indicate that aztreonam in combination with avibactam may also have important utility in infections caused by metallo-β-lactamase-producing Enterobacterales and the combination may therefore address an unmet medical need. The most common side effects of emblaveo are anemia, increased serum transaminases and diarrhea.
The development of emblaveo, and two clinical studies in particular, were supported by the Innovative Medicines Initiative’s Combacte-care project, co-funded by the EU and the pharmaceutical industry. The results arising from the project show the benefits of a collaborative approach of public and private partners.
Tags: Antibiotic resistance European Commission authorizes emblaveo antibiotic
