FDA Drug Approvals, Gastroenterology — 2022 Midyear Review

August 24, 2022

Voquezna Triple Pak ( vonoprazan/amoxicillin/clarithromycin)

Voquezna Dual Pak (vonoprazan/amoxicillin)

Vonoprazan is a first-in-class potassium-competitive acid blocker (PCAB) for treatment of H pylori in combination with clarithromycin and/or amoxicillin. It suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium-competitive manner. The combinations are supplied as prepackaged 15-day dosage regimens.

Approval of vonoprazan double (DT) and triple (TT) therapies was based on the phase 3 PHALCON-HP trial. Each proved noninferior to lansoprazole triple therapy in patients with H pylori not resistant to ampicillin or clarithromycin: vonoprazan TT (84.7%; P<0.0001) and vonoprazan DT (78.5%; P=0.0037) vs lansoprazole TT (78.8%). Am J Gastroenterol 2021 Oct;116(S634)

Other gastroenterology approvals

Rinvoq (upadacitinib) – New indication for moderate-to-severe active ulcerative colitis (UC) in adults who had inadequate response or intolerance to 1 or more TNF blockers.

Dupixent (dupilumab) – New indication approved for adults and adolescents for eosinophilic esophagitis. 

Skyrizi (risankizumab) – New indication approved for adults with Crohn disease. 


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