Spero Therapeutics, Inc. today announced that the U.S. FDA has granted Priority Review designation and confirmed acceptance for substantive review of the New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, in adult patients.

Source: Spero Therapeutics, Inc.

A complicated urinary tract infection is a urinary infection that occurs in a patient who has a genitourinary tract structural or functional abnormality. Complicated urinary infections can be linked to a wide range of genitourinary abnormalities. Interference with normal voiding is the most common cause of disease, as it prevents bacteria from being flushed out of the genitourinary tract. Infection can be caused by incomplete urinary drainage, the persistence of bacteria in biofilm on stones or indwelling devices, or increased organism introduction into the genitourinary tract due to instrumentation. The risk of disease varies depending on the abnormality. A chronic indwelling catheter, for example, is always associated with bacteriuria, whereas disease caused by a single obstructing ureteric stone can be transient, especially when the stone is removed.

• The prevalence of bacteriuria is very high, reaching 100% in patients with chronic indwelling catheters, 30% to 40% in patients with a neurogenic bladder managed by intermittent catheterization, and 50% in elderly nursing homes residents.

However, the current complicated urinary tract infection treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (Cefepime-Taniborbactam, Tebipenem Pivoxil Hydrobromide, Ceftazidime -avibactam, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for complicated urinary tract infection treatment. The key companies in the advanced development stage are Venatorx Pharmaceuticals, Inc., Spero Therapeutics, Inc., Pfizer, Wockhardt, Cubist Pharmaceuticals LLC, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market insight report on complicated urinary tract infection to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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