The European Commission has given the green light for the marketing of emblaveo, a new antibiotic developed by Pfizer to combat drug-resistant bacteria. This authorization comes after the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March. The decision was made through an accelerated evaluation mechanism due to the urgency of the need for new antibiotics.
Emblaveo is designed to treat complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, and infections caused by certain drug-resistant bacteria. It is the sixth antibiotic authorized in the EU since 2020 and aims to address the serious problem of antimicrobial resistance, which causes an estimated 35,000 deaths in the EU each year.
The new drug, to be administered intravenously, combines avibactam and aztreonam to provide a synergistic effect. Avibactam inhibits beta-lactamases, preventing them from hydrolyzing aztreonam, which targets penicillin-binding proteins to inhibit bacterial cell wall synthesis. This combination allows emblaveo to effectively combat bacteria that have become resistant to traditional antibiotics.
Clinical studies have shown that emblaveo is effective in treating infections caused by aerobic Gram-negative bacteria, including those resistant to other antibiotics. The drug has shown promise in treating infections caused by metallo-β-lactamase-producing Enterobacterales, addressing an unmet medical need in the fight against drug-resistant bacteria. Common side effects of emblaveo include anemia, increased serum transaminases, and diarrhea.
The development of emblaveo was supported by the Innovative Medicines Initiative’s Combacte-care project, a collaborative effort between the EU and the pharmaceutical industry. This partnership demonstrates the benefits of public-private collaboration in addressing public health challenges.
With the approval of emblaveo, healthcare providers in the EU will have a new tool in their arsenal to combat drug-resistant bacteria and provide patients with much-needed treatment options. The authorization of this antibiotic marks a significant step forward in the ongoing battle against antimicrobial resistance.