RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes

RedHill Biopharma, a specialty biopharmaceutical company, announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval.

Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025.

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

Dror Ben-Asher, RedHill's Chief Executive Officer, said: “The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing. Resistance to both clarithromycin and levofloxacin, estimated at up to 40%, has been rising significantly and is linked to high H. pylori treatment failure rates – with more than one in three patients failing on standard proton pump inhibitor-clarithromycin triple therapy when used in the face of known clarithromycin resistance.

“Talicia is now the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, with the ACG Guideline listing it as first-line treatment option for H. pylori infection, based on Talicia's proven superior efficacy – up to 90% effective - and safety, zero to minimal rifabutin resistance, and its convenient FDA-approved three-times daily (TID) 'breakfast, lunch, and dinner' dosing, providing for easier adherence.

“Almost 40% of the UK population are infected by H. pylori people are diagnosed with gastric cancer in the UK every day, despite confirmed eradication of H. pylori infection leading to a 75% decreased risk of gastric cancer. We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE4, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market."