Research & Development
RedHill receives FDA sNDA approval for Talicia with improved dosing regimen
18 September 2023 -

Specialty biopharmaceutical company RedHill Biopharma Ltd (Nasdaq: RDHL) announced on Monday that it has secured FDA approval for its supplemental new drug application (sNDA) for Talicia, allowing a switch to a more patient-friendly dosing regimen.

The new regimen, taken three times daily (TID) with a minimum four-hour gap and food, replaces the previous dosing schedule (Q8H). This change aims to enhance patient adherence and treatment outcomes in H. pylori eradication.

H. pylori infection affects around 35% of the US population, with approximately two million patients treated annually. Globally, over 50% of people carry this WHO Group 1 carcinogen, the primary risk factor for gastric cancer, peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Each year, more than 27,000 Americans are diagnosed with gastric cancer. H. pylori resistance to antibiotics, particularly clarithromycin, remains a challenge, leading to treatment failure in 25-40% of cases.

Talicia is an all-in-one oral capsule combining two antibiotics (amoxicillin and rifabutin) with a proton pump inhibitor (omeprazole). It is FDA-approved for H. pylori infection treatment in adults. Talicia, featuring low-dose rifabutin, tackles H. pylori's high antibiotic resistance, particularly to clarithromycin. In a pivotal Phase 3 study, Talicia achieved an 84% eradication rate in the intent-to-treat group compared to 58% in the active comparator arm (p