RedHill Biopharma Earns FDA Approval for H. Pylori Treatment

The FDA has approved RedHill Biopharma’s Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for the treatment of Helicobacter pylori infection in adults.

Talicia is a fixed-dose, all-in-one oral capsule that contains 10 milligrams of omeprazole magnesium, 250 mg of amoxicillin, and 12.5 mg of rifabutin used in combination with a protein pump inhibitor for treating adults infected with H. pylori.

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 clarithromycin-based therapies.