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

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