FDA approves Red Hill's innovative therapy, Talicia, for listing

today, Red Hill Biopharma announced that the U.S. FDA has approved the listing of its innovative therapy, Talicia, to treat adult patients infected with Helicobacter pyridosis.Talicia is an FDA-approved helicobacter pyridobacteria removal therapy based on rifabutin designed to address helicobacter pyridosis resistance to antibiotics commonly used in standard care therapies.RedHill plans to bring Talicia to the U.S. market in the first quarter of 2020.Talicia is a new fixed-dose oral capsule formulated with two antibiotics: lifobutin and amoxicillin, and a proton pump inhibitor (PPI) omeprazole. Previously, the FDA has granted Talicia Qualified Infectious Disease Products (QIDP) qualifications, priority review qualifications, and fast-track eligibility.Talicia's approval is based on positive results from two Phase 3 clinical studies. The results of one of the validated Phase 3 trials showed that 84 per cent of patients treated with Talicia had their Helicobacter pyrethrobacteria infection cleared, compared with 58 per cent in the control group, with significant statistical differences.In addition, no resistance to lifobutin, a key component of Talicia's unique formulation, was not detected in the trial. (Drug Information Network)