As resistance to standard antibiotics grows, RedHill's H. pylori regimen secures FDA approval
In 2017, the WHO designated clarithromycin-resistant H. pylori, a bacterial infection that affects more than half of the global population, a high priority for antibiotic research and development. On Monday, Israel’s RedHill Biopharma secured FDA approval for its rifabutin-based regimen to address the alarming rates of resistance to standard-of-care therapies.
The new drug will be marketed as Talicia, and the company says it plans a launch in the first quarter of 2020. The therapy is an oral capsule comprising rifabutin, amoxicillin and a proton pump inhibitor, omeprazole, and was tested in two late-stage trials, ERADICATE Hp and ERADICATE Hp2.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.