RedHill said that its Talicia has been indicated for oral administration in the form of delayed-release capsules in 10mg, or 250mg or in 12.5mg dosage.
RedHill Biopharma chief executive officer Dror Ben-Asher said: “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.”
Talicia is an advanced, fixed-dose, all-in-one oral capsule combination of the antibiotics amoxicillin and rifabutin and a proton pump inhibitor (PPI) omeprazole.
The drug marks the first rifabutin-based therapy to be approved by the US FDA for the treatment of H. pylori infection in adults.
RedHill said that it has designed Talicia to address the increasing resistance of H. pylori bacteria to the commonly used antibiotics in current standard-of-care therapies and the need for new treatments.
The regulatory approval of the drug is partially based on the results of two US Phase 3 studies for the treatment of H. pylori-positive adult patients with epigastric pain and discomfort. Both studies have demonstrated positive results for Talicia.
The company is primarily focused on the development and commercialisation of drugs for the treatment of gastrointestinal diseases. It is expected to launch the Talicia in the US in the first quarter of 2020.
Talicia Phase 3 studies lead investigator David Y Graham said: “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.
“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.”