FDA approves Helicobacter pylori infection treatment
The US FDA has granted approval for the marketing authorisation of Talicia, intended to treat adults with H. pylori infection.
The US Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium, amoxicillin and rifabutin) for the treatment of Helicobacter pylori infection in adults.
…the medication should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria”
Talicia, produced by Redhill Biopharma, is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.
The drug is a delayed-release, novel, fixed-dose oral capsule that is a combination of two antibiotics and a proton pump inhibitor (PPI).
The approval is based on two Phase III studies which saw positive results for the drug. The confirmatory study demonstrated 84 percent eradication of H. pylori infection with Talicia, compared to 58 percent in the active comparator arm.
“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia,” said Dror Ben-Asher, Chief Executive Officer of RedHill Biopharma.
However, the company has emphasised that to reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, the medication should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
The pharmaceutical company expects to launch the drug in the US in early 2020.