Israel-based RedHill Biopharma has secured the US Food and Drug Administration (FDA) approval for Talicia capsules to treat adults with Helicobacter pylori (H pylori) infection.
Talicia is a combination of antibiotics, amoxicillin and rifabutin, along with proton pump inhibitor (PPI), omeprazole.
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H pylori bacteria infects more than 50% of the global population, including 35% in the US.
Talicia is intended to address the growing resistance of the bacteria to the commonly used antibiotics in current standard-of-care therapies such as clarithromycin-based treatments.
According to estimates, the resistance of H pylori to clarithromycin nearly doubled during 2009-2013.
FDA approval supports positive results from two Phase III studies enrolling H pylori-positive adults with epigastric pain or discomfort in the US.
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By GlobalDataData from the Phase III confirmatory study revealed 84% eradication of H pylori infection when treated with RedHill’s drug versus 58% in the active comparator arm.
In participants with measurable blood levels of drug at day 13, response rates were 90.3% and 64.7% with Talicia and the active comparator, respectively.
Trial data did not show any resistance to rifabutin, a principal component of the drug. Furthermore, 1% of subjects on RedHill’s drug had adverse reaction-related treatment discontinuation.
RedHill Biopharma CEO Dror Ben-Asher said: “The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases.
“We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”
RedHill expects to launch Talicia in the US in the first quarter of next year. The company noted that the drug’s Qualified Infectious Disease Product (QIDP) designation provides market exclusivity in the country for eight years.
