U.S. FDA approves RedHill's bacterial infection treatment

[November 04, 2019]  (Reuters) - RedHill Biopharma Ltd's said on Monday its three-drug combination therapy to treat Helicobacter pylori bacterial infections had been approved by the U.S. Food and Drug Administration.

The drug, Talicia, is an oral capsule comprising two antibiotics, amoxicillin and rifabutin, as well as omeprazole, a common treatment for heartburn.

The Israel-based company said the drug was designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.

RedHill expects to launch Talicia in the United States in the first quarter next year.

Helicobacter pylori infection affects over 50% of the population worldwide, according to Redhill, and is one of the strongest risk factors in the development of gastric cancer.

(Reporting by Manas Mishra in Bengaluru; Editing by Anil D'Silva and Shinjini Ganguli)

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