Biopharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) said on Tuesday that it plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, a treatment for Helicobacter pylori (H. pylori) infection, using the Medicines and Healthcare products Regulatory Agency's (MHRA) fast-track International Recognition Procedure.

This submission will reference Talicia's US Food and Drug Administration (FDA) approval, with potential UK approval expected by Q4 2025.

Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy for H. pylori, is the leading branded treatment prescribed by US gastroenterologists and is listed as a first-line option in the American College of Gastroenterology (ACG) Guideline. The therapy addresses H. pylori resistance to other commonly used antibiotics.

H. pylori infection affects approximately 35% of the US adult population and more than 50% globally, creating a significant market opportunity. The infection is a major risk factor for gastric cancer and peptic ulcer disease, with the World Health Organization classifying it as a Group 1 carcinogen. Additional countries may accept the UK's MHRA approval as a reference for their own approval processes, potentially expediting Talicia's market expansion.