A new antibiotic has been launched in the UK for the treatment of complicated intra-abdominal infections (cIAI), acute pyelonephritis and complicated urinary tract infections (cUTI) in hospital settings.
The drug, Zerbaxa (ceftolozane/tazobactam), is a new intravenous antibiotic, which, it is hoped, will go some way in fighting against the emergence of carbapenem-resistant bacteria. This particular strain has developed in response to the standard treatments, meaning there is another option for treatment against antimicrobial resistance (AMR).
Ceftolozane/tazobactam (1g/0.5g) is a combination product consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium. It is administered every 8 hours by an intravenous infusion lasting one hour, with the treatment length normally lasting 4–14 days.
Approval for use comes after positive data was published from two pivotal Phase 3 clinical trials demonstrating non-inferiority to their comparator; one in patients with cIAI and the other in patients with cUTI. Both trials met the pre-specified primary endpoints agreed with the European Medicines Agency (EMA).
Research from the Department of Health estimates that AMR costs the European Union at least €1.5 billion per year and claims an estimated 25,000 lives, of which about 3,000 are in the UK. A government-commissioned AMR Review Team, chaired by economist Lord Jim O’Neill, has projected this to increase to 390,000 deaths per annum by 2050 in Europe and globally from an estimated 700,000 to 10 million.
David Livermore, Professor in Medical Microbiology at University of East Anglia, said: “Ceftolozane/tazobactam is very important because it’s a new antibiotic that treats Gram-negative infections, where a lot of resistance problems are now accumulating. Its activity against Pseudomonas is especially important. It overcomes both the major mechanisms – efflux and inactivation – that often compromise other cephalosporins against this difficult species. As always, there’s more to be done, more clinical trials are needed in further settings – particularly those where you find most of the difficult Pseudomonas strains.”
Dr Ron Daniels, Chief Executive at Sepsis Trust, added: “Antimicrobial resistance is one of the biggest threats facing public health in the 21st century and every stakeholder involved from pharmaceutical companies to healthcare professionals to the general public must work together to combat it. The development of new antimicrobial agents like this one and an increased awareness about the appropriate use of antibiotics will help us to continue moving in the right direction towards reducing AMR.”
Ceftolozane/tazobatam received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA in July. Based upon the CHMP decision, ceftolozane/tazobatam received marketing authorisation from the European Union in September.