Nabriva Therapeutics PLC said the U.S. Food and Drug Administration shortened the review period for the company's application for Contepo to treat complicated urinary tract infections.
The U.S. regulator now expects to make a decision on the medicine, the company's take on an existing drug called fosfomycin, by April 30 — two months ahead of originally planned.
The FDA's decision follows a move to grant the medicine's application priority review earlier this month. Contepo, an antibiotic administered by injection, also holds the FDA's qualified infectious disease product and fast-track designations to treat several serious infections, including those related to the complicated urinary tract.
According to the American Urological Association, some 150 million patients are diagnosed with urinary tract infections across the world each year, resulting in a health cost burden of $6 billion.
Nabriva's Contepo improves the absorption and effects of fosfomycin, which was originally approved over 45 years ago to treat a variety of infections in Europe.