MSD in the UK launches new antibiotic to treat complicated intra-abdominal and urinary tract infections, and acute pyelonephritis

MSD (Merck & Co., Inc., Kenilworth, NJ, USA) today announces the availability of Zerbaxa®? (ceftolozane/tazobactam) in the UK, a new intravenous antibiotic for the treatment of complicated intra-abdominal infections (cIAI), acute pyelonephritis and complicated urinary tract infections (cUTI) in hospital settings. Ceftolozane /tazobactam offers an alternative to carbapenems, currently a standard treatment for ESBL-producing organisms which have been linked to the emergence of carbapenem-resistant bacteria contributing to global antimicrobial resistance (AMR)

 Professor 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”.

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. Consideration should always be given to official guidance on the appropriate use of antibacterial agents.

The licensing of ceftolozane/tazobactam was supported by positive data 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). 

Dr Ron Daniels, Chief Executive at Sepsis Trust, said: “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/tazobactam represents a new option in the fight against AMR in the gram- negative cIAI, cUTI and acute pyelonephritis space. Recent research from the Department of Health notes that AMR costs the European Union (EU) at least €1.5 billion per year and claims an estimated 25,000 lives – an estimated 3,000 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.7  

Mike Nally, Managing Director, MSD UK and Ireland, said: “In the face of the increasing threat posed by antimicrobial resistance, MSD continues to advocate for improvements in regulatory guidance and financial incentives to support and accelerate innovation in the development of new antimicrobials, services and solutions.”

MSD’s work in AMR

In January of this year, MSD invested $9.5 billion acquiring Cubist Pharmaceuticals and their innovative pipeline of medicines, to complement MSD’s existing and growing anti-infectives portfolio. This acquisition will continue MSD’s heritage in providing new anti-infective treatments to patients, which includes its work in developing one of first methods of mass producing penicillin during the Second World War.


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