BRIEF—RedHill gets PUDFA date for H. pylori drug

The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for Talicia(RHB-105)for Helicobacter pylori infection, filed by Israel-based biotech RedHill Biopharma in May this year.

The NDA for Talicia has also been granted Priority Review designation and was assigned a target Prescription Drug User Act (PDUFA) action date by the FDA of November 2, 2019.

Commercial launch of Talicia with RedHill’s existing US sales force is planned shortly following potential FDA approval.

If approved, Talicia would be eligible for a total of eight years of US market exclusivity.

H. pylori bacterial infection affects more than 50% of the population worldwideand approximately 35% of the US population.