Eliminating the potential risk of gastric cancer FDA approved the innovation of Helicobacter pylori clearance therapy

Today, Redhill biopharma announced that the US FDA has approved its innovative treatment talicia for the treatment of adult patients with Helicobacter pylori Talicia is the only FDA approved Helicobacter pylori eradication therapy based on rifabutin, which aims to solve the problem of Helicobacter pylori resistance to antibiotics commonly used in standard nursing therapy Redhill plans to bring talicia to the U.S market in the first quarter of 2020 Helicobacter pylori infection is one of the most dangerous factors of gastric cancer, which is classified as a kind of carcinogen It is also one of the main risk factors for peptic ulcer and gastric mucosa associated lymphoid tissue (MALT) lymphoma It increases the incidence of non cardiac gastric cancer and MALT lymphoma by six times Around the world, Helicobacter pylori infection affects more than 50% of adults According to statistics, from 2009 to 2013, the resistance of Helicobacter pylori to clindamycin, a commonly used antibiotic in standard nursing therapy, more than doubled Patients urgently need new Helicobacter pylori clearance therapy to fight against this drug resistance Talicia is a new fixed dose oral capsule, which contains two kinds of antibiotics: rifabutin and amoxicillin, and one kind of proton pump inhibitor (PPI), omeprazole Previously, FDA has awarded talicia qualified infectious disease product (qidp) qualification, priority review qualification, and fast track qualification Talicia's approval is based on the positive results of two phase 3 clinical studies The results of one of the confirmatory phase 3 trials showed that 84% of patients treated with talicia had been cleared of H.pylori infection, compared with 58% in the control group, with a statistically significant difference In addition, no resistance to rifabutin was detected in the trial and rifabutin is a key component of talicia's unique formula Photo source: Redhill website "Talicia has excellent safety and efficacy, and is not affected by high resistance to clindamycin and metronidazole, providing a new treatment option for patients with Helicobacter pylori," David y of Baylor College of medicine, Houston "25% to 40% of patients treated with clindamycin do not respond well because of the increasing drug resistance," said Graham, MD Clinical studies have shown that talicia can effectively eliminate Helicobacter pylori, and no resistance to rifabutin has been detected in the trial " "FDA's approval of talicia embodies our dedication and long-term commitment to the development of gastrointestinal disease treatment drugs," said Dr Ben Asher, chief executive officer of Redhill "Here, we thank the patients, researchers and Redhill team who participated in the talicia study for their unremitting efforts and hard work to make this important milestone come true " reference material: [1] RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H pylori in Adults, Retrieved November 4, 2019, from https:// A kind of