FDA Approves Talicia for sNDA

RedHill Biopharma announced that FDA has approved Talicia for a supplemental new drug application (sNDA).

Previously, the drug’s dosing regimen required patients to take the medication every eight hours with food. The new dosing regimen has patients taking the medication three times a day, at least four hours apart, with food.

The new regimen allows patients to take the medication on a more normalized eating schedule, such as having it with breakfast, lunch, and dinner.

RedHill’s chief medical officer Dr. June Almenoff, MD, PhD, said in a press release, “Talicia is unique in that it is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. Both its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication. RedHill is committed to advancing GI and infectious disease management through patient-focused innovation. Through our successful collaboration with Certara, utilizing their Simcyp™ Simulator for physiologically based pharmacokinetic (PBPK) modeling, we have demonstrated therapeutic equivalence between TID and Q8H dosing, enabling us to provide what we believe is a more flexible Talicia regimen that we believe will be beneficial for the patient experience."

Source

(Sept. 18, 2023); PR Newswire; RedHill Announces FDA sNDA Approval for Talicia; https://www.prnewswire.com/news-releases/redhill-announces-fda-snda-approval-for-talicia-301930308.html