ECCMID 2018: Avycaz set for paediatric label expansion following Phase IIb trials

23rd April 2018 (Last Updated April 23rd, 2018 14:33)

The results from two Phase IIb paediatric studies investigating the safety, efficacy, and pharmacokinetics of Avycaz for the treatment of complicated intra-abdominal infections and complicated urinary tract infections were presented at the 2018 European Congress of Clinical Microbiology and Infectious Diseases.

The results from two Phase IIb paediatric studies investigating the safety, efficacy, and pharmacokinetics of Avycaz (ceftazidime/avibactam) for the treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), were presented at the 2018 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The results showed that Avycaz in combination with metronidazole was a safe and efficacious treatment for cIAIs and cUTIs in paediatric patients, paving the way for an eventual label expansion.

Originally developed by AstraZeneca and approved by the FDA for the treatment of certain Gram-negative infections in adults in 2015, Avycaz (also known as Zavicefta) is now marketed by Allergan in the US and by Pfizer in the rest of world. Avycaz is a fixed-dose combination of ceftazidime, a third-generation cephalosporin, and avibactam, a beta-lactamase inhibitor. It is usually used an alternative therapy for patients who have exhausted other options, primarily those who are resistant to ceftazidime monotherapy.

The multicenter Phase IIb trial investigating safety and efficacy of Avycaz with metronidazole in 83 paediatric cIAI patients was conducted using meropenem as an active comparator. Avycaz demonstrated a favourable clinical response rate in ≥90% of participants across all measures of efficacy, and adverse events (AEs) were comparable across the two treatment groups.

In the parallel Phase IIb study investigating Avycaz in paediatric patients with cUTIs, 95 patients were included in the endpoint analysis. AEs were again comparable to the active comparator, cefepime, and the clinical and microbiological responses to Avycaz were also comparable to cefepime. This included a patient which was positive for pathogens not susceptible to ceftazidime monotherapy. A significant proportion of the participants had impaired renal function, 34.2% and 25% of the Avycaz and cefepime groups respectively had creatinine clearance rate of ≥50 to <80mL/min, demonstrating safety in this higher risk patient population. Across both the cIAI and cUTI paediatric clinical trials, no new AEs associated with Avycaz treatment were identified from the previously conducted trials in adults.

With these paediatric results Pfizer will be well positioned to seek label-expansion to include paediatric patients as young as three months of age for both cIAIs and cUTIs. Due to a lack of antibiotic therapies for infections involving multidrug resistant (MDR) pathogens for this patient population, GlobalData expects Avycaz to see substantial uptake upon a label expansion.

Related reports

GlobalData (2017). PharmaPoint: Healthcare-Associated Gram-Negative Infections – Global Drug Forecast and Market Analysis to 2026, August 2017, GDHC147PIDR

For more insight and data, visit the GlobalData Report Store - Drug Development Technology is part of GlobalData Plc.