U.S. FDA approves RedHill’s bacterial infection treatment
(Reuters) – RedHill Biopharma Ltd 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, sending its shares up 25%.
The drug, Talicia, is an oral capsule comprising two antibiotics, amoxicillin and rifabutin, as well as omeprazole, a common treatment for heartburn.
The treatment is expected to be launched in the first quarter of next year. The company declined to disclose the planned price of the drug.
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.
“H. pylori is increasingly alarming as it is one of those so-called “superbugs” that have been developing a resistance to existing antibiotics used in standard of care,” Chief Executive Officer Dror Ben Asher told Reuters.
The approval was based on clinical trials where no resistance was found against rifabutin, one of the components of the treatment. The drug also eradicated H. Pylori infections by 84% in its clinical studies.
Drug resistance is driven by the misuse and overuse of antibiotics and other antimicrobials, which encourages bacteria to evolve to survive by finding new ways to beat the medicines.
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