RedHill Biopharma leaps as FDA approves H. pylori drug Talicia

4 November 2019

The US Food and Drug Administration has approved Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10mg/250mg/12.5mg for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Israeli drugmaker RedHill Biopharma (Nasdaq: RDHL), whose shares rocketed more than 35% to 325.00 shekels in Tel Aviv trading this morning, today said it expects to launch Talicia in the USA 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.

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