FDA rejects Contepo application for complex urinary tract infection

Nabriva Therapeutics recently announced that theFDAhas again rejected Contepo's application for treatment of complex urinary tract infections(including acute phytomyelitis, cUTI) due to unresolved manufacturing problemsLast year, the FDA rejected Nabriva's application to address issues related to the contract manufacturer's facility inspections and manufacturing defectsits European contract manufacturers are ready for regulatory checks, according to NabrivaHowever, the FDA was unable to conduct on-site inspections due to travel restrictions under the new Crown outbreak, so previous issues have not been satisfactorily resolvedNabriva noted that the FDA did not ask for any new clinical data or any other concerns about The safety of Contepo in its latest full response letterThe company said it plans to meet with the FDA to discuss next stepsContepo, formerly known as ZTI-01, is an intravenous phosphamycin, a drug that has been granted by the FDA for fast-track treatment for serious infectionsPhosphamycin is effective in both gram-positive and negative bacteria, and its mechanism is to inhibit the synthesis of bacterial cell walls, and prevent bacteria from using the substances to synthesize the first step of the cell wall, thus playing a bactericidal effect