Approvals

The drug is also indicated for the treatment of infections from aerobic Gram-negative organisms in adult patients who have limited treatment options.

This approval follows results from the previously reported phase 3 programme, which included the REVISIT and ASSEMBLE trials, assessing the safety, efficacy and tolerability of Emblaveo in treating serious infections due to Gram-negative bacteria. The results demonstrated that the drug is effective and well-tolerated, and no new safety findings were reported compared to aztreonam alone.

This marketing authorisation is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.

Marketing authorisation applications for the drug are expected to be submitted in other countries imminently.

Alexandre de Germay, chief international commercial officer and executive vice president at Pfizer, commented: “The European Medicines Agency’s (EMA) accelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of antimicrobial resistance (AMR). With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”

Yehuda Carmeli, head of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study, added: “For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat. The approval of Emblaveo is welcome news for the infectious disease community and provides new hope to critically ill patients affected by AMR.”