Nabriva Therapeutics PLC resubmitted an application to the U.S. Food and Drug Administration seeking approval of its injectable medicine Contepo to treat complicated urinary tract infections after an initial rejection earlier in the year.
The Dublin-based biopharmaceutical company's stock plummeted on May 1 after the FDA rejected the initial application and requested Nabriva to address issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers before seeking approval. The FDA had not requested any new clinical data or raised any concerns related to the safety of the drug.
Nabriva is seeking approval of Contepo to treat complicated urinary tract infections, including acute pyelonephritis — a type of urinary tract infection that usually begins in the bladder and travels to one or both the kidneys.
Contepo — which is an antibiotic administered by injection — improves the absorption and effects of fosfomycin, which was originally approved over 45 years ago to treat a variety of infections in Europe.
The company said in a Dec. 20 press release that it has refiled the new drug application based on an outcome of a meeting with the FDA to get clarity on the information requested by the U.S. regulator.
Nabriva expects a six-month review period by the FDA for Contepo.