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    Home > Biochemistry News > Biotechnology News > The new antibiotic Contepo's treatment for complex urinary tract infections was again rejected by the FDA.

    The new antibiotic Contepo's treatment for complex urinary tract infections was again rejected by the FDA.

    • Last Update: 2020-07-29
    • Source: Internet
    • Author: User
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    Nabriva Therapeutics, a biopharmaceutical company dedicated to the development of innovative anti-infective drugs for serious infections, announced that it has received a full response from the FDA (CRL) to reject the application for a new drug (NDA) for the treatment of complex urinary tract infections (cUTI, including acute nephritis) of its antibiotic product Contepo (fosfomycin, phosphamycin injections)note, last year the FDA rejected a Nabriva application to address issues related to the contract manufacturer's facility inspections and manufacturing defectsThis rejection was affected by the outbreakNabriva said that while its European manufacturing partners were ready to be inspected by regulators, the FDA was not currently able to conduct on-site inspections because of travel restrictionsIn the CRL, the FDA does not require any new clinical data, nor does it raise any other concerns about the safety or effectiveness of ContepoNabriva plans to hold a Class A meeting with the FDA to discuss the next steps and how the FDA can successfully complete inspections by foreign agencies in the futurecUTI refers to infections caused by potential urinary tract function or structural abnormalities or catheterization in patients, including patients with acute phytopharyophyritisIt is estimated that 3 million Gram-negative cUTI cases are treated in the United States each year, of which about 40% are suspected to be caused by drug-resistant strainsFailure to receive effective treatment will lead to an increase in treatment failure rates, which in turn can lead to longer hospital stays, recurrences, re-hospitalizations and increased mortality, each result ingesting significant resources and financial burdens on the health care systemOne of the causes of cUTI is Enterobacteriaceae, a multidrug-resistant (MDR) strain of Gram-negative bacteriaEcoli can produce broad-spectrum-lactamase (ESBL), a chemical that can cause certain antibiotics to fail when treating bacterial infections such as cUTIAs a result, cUTI poses a serious and rapidly emerging health threat to inpatients, especially in intensive care unitsContepo is an intravenous epoxy antibiotic with broad-spectrum activity for Gram-negative and Gram-positive bacteria, including ESBL-producing Ecoli and other contemporary multidrug resistant (MDR) strainsAbout 25% of cUTI is caused by MDR bacteria and treatment is limitedNon-clinical data show that Contepo works with some other antibiotics to increase the ability to kill bacteria and restore sensitivity to other drug-resistant drugs The initial focus of the Contepo development project was to obtain regulatory approval for cUTI treatment through the Pivotal ZEUS Study (ZTI-01 Therapeutics and Safety Study) In the ZEUS study, Contepo reached the primary endpoint in the patient population, which was statistically non-de-seisciated with pullathalcilin and tapyritel batan In October 2018, Nabriva filed an NDA with the FDA seeking regulatory approval for Contepo's treatment of cUTI, including acute nephritis Unfortunately, it was not approved for production defects Source: Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO ™ (fosfomycin) for injection.
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