RedHill Biopharma gets FDA green light for Talicia
RedHill Biopharma has received the Food and Drug Administration’s clearance for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules in dosage strengths of 10mg/250 mg/12.5 mg for the treatment of Helicobacter pylori, or H. pylori infection in adults.
The company plans to launch Talicia in the first quarter of 2020.
Talicia is the first and only FDA approved rifabutin-based H. pylori therapy and is designed to address the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy, the company said.
H. pylori affects approximately 35% of the U.S. adult population; it is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer, according to the company.