Top-line results from two Phase III studies showed that AstraZeneca's experimental antibiotic ceftazidime-avibactam (CAZ-AVI) was non-inferior to meropenem as a treatment for hospitalised adults with complicated intra-abdominal infections (cIAI), the company reported Tuesday. "We are very encouraged by these results...especially where antibiotic resistance poses a threat to treatment," commented the drugmaker's chief medical officer Briggs Morrison. AstraZeneca, which is developing CAZ-AVI with Actavis' Forest Laboratories subsidiary, said that data from the RECLAIM-1 and RECLAIM-2 trials could form the basis of regulatory submissions seeking approval for a broader range of indications, in line with new guidelines from the European Medicines Agency on the evaluation of medicines to treat bacterial infections. The company indicated that an EU filing is expected in the first quarter of 2015. The RECLAIM-1 and RECLAIM-2 studies randomised 1066 hospitalised adults with cIAI to receive CAZ-AVI, administered intravenously as a two-hour infusion, plus metronidazole, administered intravenously as a 60-minute infusion, or meropenem, administered intravenously as a 30-minute infusion. AstraZeneca noted that results from the studies were analysed as a single-pooled dataset in agreement with the FDA and EMA. For the EMA, the co-primary analysis was conducted at the test of cure (TOC) in the modified-intent-to-treat (MITT) and clinically evaluable patient populations, while for the FDA, the primary analysis was conducted at the TOC in the microbiological MITT population.
The RECLAIM-1 and RECLAIM-2 studies randomised 1066 hospitalised adults with cIAI to receive CAZ-AVI, administered intravenously as a two-hour infusion, plus metronidazole, administered intravenously as a 60-minute infusion, or meropenem, administered intravenously as a 30-minute infusion. AstraZeneca noted that results from the studies were analysed as a single-pooled dataset in agreement with the FDA and EMA. For the EMA, the co-primary analysis was conducted at the test of cure (TOC) in the modified-intent-to-treat (MITT) and clinically evaluable patient populations, while for the FDA, the primary analysis was conducted at the TOC in the microbiological MITT population. Results from the studies showed that for the main goal of a clinical cure rate 28 to 35 days after randomisation, CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. In addition, AstraZeneca said that the experimental antibiotic also treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem. The company added that the adverse event rate for CAZ-AVI in combination with metronidazole was similar to meropenem, with the most commonly adverse events for AstraZeneca's therapy being diarrhoea, nausea, vomiting and fever. AstraZeneca holds the global rights to commercialise CAZ-AVI, with the exception of North America where Forest holds rights. The therapy consists of the cephalosporin antibiotic ceftazidime and the non-beta lactam beta-lactamase inhibitor avibactam, which is designed to protect ceftazidime from being broken down by beta-lactamases. CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections, with studies under way in complicated urinary tract infections (cUTI), nosocomial pneumonia and for the treatment of cIAI and cUTI patients with ceftazidime-resistant infections.
and based upon recen email promotional announcements this company has put a whole lot of people in charge who have absolutely no idea what those paragraphs above even mean. god help us all and save us from incompetent hospital division management
