echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical Research Articles > FDA accepts new drug application for innovative Helicobacter pylori removal therapy Talicia

    FDA accepts new drug application for innovative Helicobacter pylori removal therapy Talicia

    • Last Update: 2020-06-09
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    classified as a type 1 carcinogen for stomach cancer, Helicobacter pylori infection is one of the strongest risk factors for stomach cancer, and is also one of the main risk factors for peptic ulcers, as well as gastric mucosa-related lymphoma (MALT) lymphoma, which can improve the incidence of non-bacterial gastric cancer and MALT lymphoma by up to 6 timestoday, RedHill Biopharma, a bio
    pharmaceutical(http://http://
    company focused on gastrointestinal diseases, announcedtoday thatFDA(http://accepted itsnew drug(http://application (NDA) for its innovative Helicobacter pylori removal therapyThe application is expected to be approved by November 2, 2019About Talicia
    Talicia (RHB-105) is a new fixed-dose oral capsule with a formula of 2 antibiotics: rifabutin (rifbuttin) and amoxicillin (amoxicin), and 1 proton pump inhibitor (PPI) omeprazole (omeprazole) Given the high resistance of Helicobacter pylori to antibiotics commonly used in standard care therapies (mainly klinmycin and mitanezole), their clinical efficacy continues to decline, patients are in urgent need of a new type of Helicobacter pylori removal therapy previously, the FDA had previously granted Talicia qualified infectious disease products (http:// (QIDP) and fast-track eligibility 's NDA application for THE
    of THE
    OF THEOFABLE IS BASED ON THE TOP LINE RESULTS OF THE PHASE 3
    Test (http:// THE 15th results showed that 84% of patients in the Taliciagroup had H coli infection removed, compared with 58% in the control group, with a high statistically significant difference in data (p0.0001), reaching the main endpoint of the trial in addition, (http:// were not tested in the trial resistance to rifabutin, a key component of Talicia's unique formulation
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.