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Old antibiotic nears new FDA approval after positive trials

Published on 07/04/17 at 10:34am

Zavante, a biotech company based in San Diego, has unveiled positive results from a recent Phase II/III trials that could see an antibiotic commonly prescribed in Europe enter the US market for the first time. The antibiotic is fosfomycin and has been in existence for 45 years, but it could now be used in the US for the first time due to the GAIN Act.

The GAIN (Generating Antibiotic Incentives Now) Act was signed into existence by President Obama, with the aim of encouraging more development of antibiotic to combat the growing issue of antibiotic-resistance. It was the GAIN Act that made Zavante look to develop Zoly, as its intravenous form of the antibiotic is known; the passing of the act means that certain antibacterial and antifungal drugs can qualify for an additional five years of market exclusivity.

The exclusivity made the drug financially viable to develop and the results from Zavante’s most recent trial justify the decision to pursue development of the antibiotic. The overall success rate was found to be 64.7% against standard treatment results of 54.5%. Clinical cure rates were also found to be similar between the two drugs, at 90.8% and 91.6% respectively.

Standard treatment is a combination of piperacillin and tazobactam, produced by Pfizer, which is increasingly struggling with resistant targets.

"Increasing antimicrobial resistance is significantly limiting the number of therapies available to treat infections in U.S. hospitals. We believe that Zolyd is an important antibiotic with a novel mechanism of action that, if approved, will help fill the void and address the unmet need. The strong trial results advance our goal of making Zolyd available to U.S. physicians and their patients," said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics.

Should Zolyd receive FDA approval, it would enter the market a full four decades later. Zavante plans to file with the FDA early in 2018.

Ben Hargreaves

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