RedHill to file FDA-approved Talicia for UK marketing

Israeli-headquartered RedHill Biopharma (Nasdaq: RDHL) today revealed its plan to submit a UK marketing authorization application (MAA) for Talicia (low-dose rifabutin-triple therapy) 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 US Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025, said RedHill, whose shares fell more than 13% to $2.61 following the announcement.

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 US gastroenterologists. Some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia.