Drug company GSK stopped its new antibiotic drug study a year early and is preparing to submit for FDA approval after finding it effective in treating urinary tract infections, CNN reported Nov. 3.
Gepotidacin, the first new type of antibiotic developed in more than 20 years for UTIs, works by blocking enzymes that bacteria need to unzip their DNA so they can multiply. It comes as a pill. The clinical trials of 3,000 women compared gepotidacin with nitrofurantoin, the current first-line antibiotic therapy, the report said.
GSK stopped the trial after finding its new antibiotic to be just as effective as nitrofurantoin. The company plans to publish its findings in a medical journal and submit the data to the FDA for approval next year, GSK told CNN.
"Stopping studies in such circumstances is a pretty rare occurrence in the industry. So it's something I'm absolutely delighted about, both from public health and from a company perspective," GSK Chief Scientific Officer Tony Wood, PhD, said in an interview with CNN.