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Allergan has announced veritable topline results from RECAPTURE 1 and 2, the depending Phase III studies evaluating the antibiotic Avycaz (ceftazidime-avibactam) being of the cl~s who a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis.
Avycaz consists of a cephalosporin, ceftazidime, one established treatment for serious bacterial infections, and the foremost and only non-beta lactam beta-lactamase inhibitor, avibactam. The adding of avibactam protects ceftazidime from root broken down by certain beta-lactamases that are produced ~ dint of. these resistant bacteria.
Ceftazidime-avibactam was approved through the US Food and Drug Administration (FDA) while Avycaz in February 2015 for the management of cUTI including pyelonephritis and complicated intra-abdominal infections (cIAI), in combination with metronidazole, caused ~ dint of. designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa with respect to patients 18 years of age and older. Avycaz accepted a priority review based on Phase II facts from the company’s clinical progress to maturity program and supporting in vitro data, and as such should be unsociable for use in patients who get limited or no alternative treatment options. In the EU, the regulatory submissiveness seeking approval for a run of indications, was accepted and validated ~ the agency of the European Medicines Agency (EMA) in May 2015 and is publicly under review.
Avycaz was statistically non-less valuable to doripenem in two Phase III studies
The global RECAPTURE 1 and 2 Phase III studies evaluated the preservation and efficacy of Avycaz administered intravenously for example a two-hour infusion, compared to doripenem, administered intravenously while a 30-minute infusion, in hospitalised person of mature age patients with cUTI, including pyelonephritis. Data from the studies were analysed in the same proportion that a single-pooled dataset with the agreement of the US FDA and the EMA.
In the RECAPTURE 1 and RECAPTURE 2 Phase III studies, Avycaz met the objective of statistical non-inferiority compared to doripenem in the place of both the EMA primary and FDA co-chief endpoints.
Avycaz was also effective in treating cUTI patients infected by ceftazidime-resistant bacteria.
“We are to a high degree pleased by these results, which we figure to submit to the FDA to farther support the use of Avycaz being of the cl~s who a treatment option for patients with these serious and life-threatening complicated urinary sermon infections,” said David Nicholson, Executive Vice President & President, Global Brands R&D at Allergan.
Allergan plans to submit this facts as a supplemental New Drug Application (sNDA) to the FDA by the end of 2015.
Allergan is jointly developing Avycaz with AstraZeneca.
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