FDA approves Talicia for Helicobacter pylori (H. pylori) infection.- RedHill Biopharma

RedHill Biopharma announced that the FDA has approved Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults. RedHill expects to launch Talicia in the U.S. in the first quarter of 2020 with its dedicated sales force. Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-2013.

Talicia�s approval is based, in part, on the results of two positive Phase III studies in the U.S. for the treatment of H. pylori-positive adult patients complaining of epigastric pain and/or discomfort. The confirmatory Phase III study of Talicia demonstrated 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (p<0.0001). further, in an analysis of data from this study, it was observed that subjects with measurable blood levels of drug at day 13 had response rates of 90.3% in the talicia arm vs. 64.7% in the active comparator arm3. no resistance to rifabutin, a key component of talicia, was detected in the study. treatment discontinuation due to an adverse reaction occurred in 1% of patients (4 305) receiving talicia. the adverse reactions leading to the patients� discontinuation of talicia were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, respectively.>