The New Drug Application (NDA) for Talicia for the treatment of Helicobacter pylori (H. pylori) infection has been submitted to the Food and Drug Administration (FDA) by RedHill Biopharma.

Talicia is a novel, fixed-dose oral capsule that combines the antibiotics rifabutin and amoxicillin, and the proton pump inhibitor omeprazole.The NDA submission was supported by data from two phase 3 studies and 2 pharmacokinetic studies.

In ERADICATE Hp, Talicia demonstrated 89.4% efficacy in eradicating H. pylori infection (P <.001), while in the confirmatory study (ERADICATE Hp2),  H. pylori eradication was observed in 84% of patients in the Talicia arm vs 58% of those in the active comparator group (P <.0001). “In our clinical study, no H. pylori resistance to rifabutin, one of the key ingredients in Talicia, was identified pre and post treatment,” said Ira Kalfus, MD, RedHill’s medical director.

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According to the Company, current standard-of-care therapies for H. pylori infection fail in approximately 30-40% of patients due to increasing antibiotic resistance. “We believe Talicia has the potential to become the new first-line, standard-of-care therapy for H. pylori infection,” added Kalfus.

If approved, Talicia is expected to be available in the 4th quarter of 2019.

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