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# RedHill Bio Gains H. Pylori Approval
- URL: https://www.fdaweb.com/redhill-bio-gains-h-pylori-approval/
- Published: 2019-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:51:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145411

FDA has approved a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg /250 mg/12.5 mg for treating *Helicobacter pylori* (*H. pylori*) infection in adults. The company says Talicia is the only rifabutin-based therapy approved for treating the infection and is designed to address the high resistance of *H. pylori* bacteria to current clarithromycin-based standard-of-care therapies.

Talicia’s approval is based on data from two positive Phase 3 studies *H. pylori*\-positive adult patients complaining of epigastric pain or discomfort. “The confirmatory Phase 3 study of Talicia demonstrated 84% eradication of *H. pylori* infection with Talicia vs. 58% in the active comparator arm (p<0.0001),” the company says. “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 arm.”