FDA approves RedHill Biopharma’s Talicia to combat Helicobacter pylori infection
RedHill Biopharma is celebrating after the FDA chose to award marketing authorisation to Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the treatment of Helicobacter pylori (H pylori) infection in adult patients.
The ruling covers three delayed-release formulations in 10 mg/250 mg/12.5 mg capsules to combat the infection and marks the first approval by the US agency of a rifabutin-based therapy in this indication.
H pylori affects around 35% of the US population and infection is known to be the strongest risk factor for developing peptic ulcer disease, gastritis and non-cardia gastric cancer.
“Talicia offers patients a much-needed new treatment option for H pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance,” explained Professor David Y Graham, Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine and Lead Investigator of the Talicia Phase 3 studies. “The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases.”
Dror Ben-Asher, Chief Executive Officer of RedHill Biopharma, also commented on the approval: “The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work. We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”
RedHill also announced its intention to launch the drug in the first quarter of next year.
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