FDA Approves Talicia for Helicobacter pylori Infections

The FDA has approved Talicia (RedHill Biopharma), a triple combination therapy comprised of omeprazole magnesium, amoxicillin, and rifabutin for the treatment of Helicobacter pylori (H. pylori) infections in adults. 

Approval for the first and currently only rifabutin-based H. pylori treatment was based upon results from two phase 3 studies comparing Talicia with comparative treatments, according to an official release. Talicia was shown to achieve 84% eradication of H. pylori infection compared to 58% in the comparator arm. Similarly, patients’ blood levels taken at day 13 indicated a 90.3% response rate to Talicia, compared to only 64.7% response rate in the comparator arm. Resistance to rifabutin was not detected throughout the studies, and only 1% of patients discontinued treatment due to adverse events. 

“H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer. Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade,” said Colin Howden, MD, Hyman professor of medicine & chief of the division of gastroenterology at the University of Tennessee Health Science Center, in a statement. “Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

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Talicia is contraindicated in patients with known hypersensitivity to omeprazole, amoxicillin, or any other beta-lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of Talicia.

Warnings and precautions for Talicia include Clostridioides difficile-associated diarrhea, acute interstitial nephritis, cutaneous and systemic lupus erythematosus. Hormonal contraceptives should be reduced while taking Talicia. 

Adverse events reported with the use of Talicia include diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.