FDA Approves 3-Drug Combo for Treatment of H. pylori in Adults

Officials with the FDA have approved the 3-drug combination of omeprazole magnesium, amoxicillin, and rifabutin (Talicia, RedHill Biopharma) for the treatment of Helicobacter pylori (H. pylori) infection in adults, according to a press release.

A combination of 2 antibiotics and a proton pump inhibitor, omeprazole magnesium, amoxicillin, and rifabutin will be available in delayed-release capsules 10 mg¹/250 mg/12.5 mg.

With increasing bacterial resistance, H. pylori, which affects over 50% of the population worldwide, is becoming more difficult to eradicate. Current standard-of-care therapies fail in approximately 25% to 40% of patients who remain H. pylori positive, as resistance continues to grow against commonly used antibiotics clarithromycin and metronidazole.

According to the World Health Organization, clarithromycin-resistant H. pylori is categorized as a pathogen for which there is a high priority need to develop new treatments.

Omeprazole magnesium, amoxicillin, and rifabutin, a novel, fixed-dose, all-in-1 oral capsule, is now the first FDA-approved rifabutin-based pylori therapy, according to RedHill Biopharma. The treatment is designed to address the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy.

The approval is based, in part, on the results from 2 phase 3 studies evaluating omeprazole magnesium, amoxicillin, and rifabutin for the treatment of patients with H. pylori with epigastric pain and/or discomfort.

According to the confirmatory phase 3 study, omeprazole magnesium, amoxicillin, and rifabutin demonstrated 84% eradication of H. pylori infection versus 58% in the active comparator arm. An analysis of the data showed that patients with measurable blood levels of drug at day 13 had response rates of 90.3% in the omeprazole magnesium, amoxicillin, and rifabutin arm versus 64.7% in the active comparator arm.

Additionally, no resistance to rifabutin was detected in the study. Only 1% of patients receiving omeprazole magnesium, amoxicillin, and rifabutin discontinued treatment due to an adverse event (AE). Common AEs leading to discontinuation were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis.

“H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of cancer,” Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine and Chief of the Division of Gastroenterology, University of Tennessee Health Sciences Center, said in a statement. “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. 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.”

Omeprazole magnesium, amoxicillin, and rifabutin should only be used to treat or prevent infection that are proven or strongly suspected to be caused by bacteria, according to the press release.

RedHill Biopharma expects to launch omeprazole magnesium, amoxicillin, and rifabutin in the first quarter of 2020, the company said.

Reference

RedHill Biopharma Announces FDA Approval of Talicia for Treatment of H. pylori in Adults [news release]. RedHill Biopharma’s website. https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1395&PID=0&IID=13236. Accessed November 4, 2019.