RedHill Announces FDA sNDA Approval for Talicia®
RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 18, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. This differs from the previously approved dosing regimen (Q8H), which required dosing every eight hours with food, by enabling patients to follow a convenient "breakfast, lunch and dinner" dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.
- "H. pylori treatment can be challenging for patients as most regimens require different pills to be taken multiple times per day.
- "This new dosing regimen further supports the value of Talicia as an empirically prescribed first-line therapy for H. pylori eradication.
- "Talicia is unique in that it is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori.
- "RedHill is committed to advancing GI and infectious disease management through patient-focused innovation.