News Scan for Oct 02, 2018

Combo antibiotic for CRE
Food safety and trade agreement

Combo antibiotic for CRE infections performs well in phase 3 trial

The results of a phase 3 randomized, controlled clinical trial show that monotherapy with the antibiotic/beta-lacatamase inhibitor combination Vabomere (meropenem-vaborbactam) in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections was associated with increased clinical cure, decreased mortality, and reduced kidney toxicity compared with the best available therapy (BAT). The results were published yesterday in Infectious Diseases and Therapy.

In the Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO) II trial, 77 patients with confirmed CRE infection from 27 hospitals in eight countries were randomized 2:1 to receive meropenem-vaborbactam alone for 7 to 14 days or BAT (mono/combination therapy with polymyxins, aminoglycosides, tigecycline; or ceftazidime-avibactam alone). Forty-seven patients with confirmed CRE infection formed the primary analysis population. Efficacy end points included clinical cure, day-28 all-cause mortality, microbiologic cure, and overall success (clinical cure plus microbiologic eradication). The most common infection types were bacteremia and complicated urinary tract infections (cUTIs).

In the primary analysis population, cure rates were 65.6% (21/32) for patients receiving meropenem-vaborbactam and 33.3% (5/15) for BAT patients at end of treatment and 59.4% (19/32) and 26.7% (4/15) at test of cure. Day-28 all-cause mortality was 15.6% (5/32) and 33.3% (5/15) for meropenem-vaborbactam versus BAT, respectively. In the safety population, meropenem-vaborbactam was associated with fewer drug-related adverse events (24% [12/50] vs. 44% [11/25]), fewer serious adverse events (34% [17/50] vs. 44% [11/25]), and fewer kidney-related adverse events (4% [2/50] vs. 24% [6/25]) than BAT was.

Exploratory risk-benefit analyses of composite clinical failure or nephrotoxicity also favored meropenem-vaborbactam over BAT, 31.3% (10/32) to 80% (12/15).

The authors of the study conclude that the results indicate that meropenem-vaborbactam, which was approved by the US Food and Drug Administration in 2017 for use in cUTI patients based on results from the TANGO I trial, "will be a valuable addition to the antimicrobial armamentarium against CRE pathogens."
Oct 1 Infect Dis Ther study

New North American trade deal keeps food safety measures intact

The new version of the North American trade deal announced yesterday leaves existing food safety provisions in place, though two Canadian think tanks had proposed including at least a bilateral food protection system between the United States and Canada, Food Safety News (FSN) reported today.

Earlier in the discussions, the Canadian Agri-Food Policy Institute and the Canada Institute of the Wilson Center produced an 8-page discussion paper that urged Canada and the United States to establish a joint risk assessment organization for food safety.

According to FSN, the section of the new agreement that covers sanitary and phytosanitary measures doesn't include any of the suggested reforms and contains language similar to the previous North American Free Trade Agreement (NAFTA) objectives, such as strengthening communication and cooperation between the parties and advancing science-based decision making.

Expert panels subjected to legal oversight and relying on relevant international standards will handle scientific and technical food safety disputes among the parties, according to the agreement, which is now called the United States-Mexico-Canada Agreement (USMCA).
Oct 2 FSN report

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