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RedHill Biopharma Announces Approval for Talicia®

Tuesday, September 19, 2023

RedHill Biopharma has received approval from the U.S. Food and Drug Administration (FDA) for a change in the dosing regimen of its drug, Talicia, used for the eradication of H. pylori infection. 

Talicia is a unique oral capsule that combines two antibiotics, amoxicillin and rifabutin, along with a proton pump inhibitor (PPI), omeprazole. It is the only low-dose rifabutin-based therapy approved for H. pylori treatment, offering a solution for cases where H. pylori has developed resistance to other antibiotics. The formulation and components of Talicia are optimised to ensure effective eradication of H. pylori.

H. pylori treatment can be complex for patients, often requiring multiple pills to be taken throughout the day. Simplified regimens like the new TID dosing of Talicia can greatly improve patient adherence, making it an attractive option for healthcare providers when choosing an H. pylori eradication therapy.

The flexibility in dosing, coupled with Talicia's proven efficacy, tolerability, and resistance profile, along with its status as the only all-in-one formulation available, positions it as a strong choice for first-line therapy in the empiric treatment of H. pylori infection. 

Talicia offers potential advantages over clarithromycin-based regimens for most patients, making it a promising option in the fight against H. pylori infection.

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