1. Scrip
  2. >>Therapy Areas
  3. >>Anti-infective

Spero's Oral Tebipenem HBr Stacks Up To IV Carbapenem In Phase III

 
• By Jessica Merrill

Tebipenem HBr, a potential first oral carbapenem antibiotic, will be submitted to the US FDA under a rolling NDA in the first quarter of 2021 for complicated urinary tract infection and acute pyelonephritis.

Paper_Planes
Spero hopes to succeed in antibiotics, where others have not • Source: Shutterstock

Spero Therapeutics, Inc. is on track to seek approval of the first oral carbapenem antibiotic in the US, providing a new option for patients with complicated Gram-negative infections currently treated with intravenous antibiotics.

The company said on 8 September that it expects to begin a rolling new drug application for tebipenem pivoxil hydrobromide for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) with the US Food and Drug Administration in the first quarter of 2021, based on the

More from Anti-infective

More from Therapy Areas

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 
• By Jessica Merrill

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 
• By Alaric DeArment

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.