Phathom: FDA OKs Treatment of H. pylori Infection in Adults

 

• Planning for a December 2023 U.S. launch for H. pylori, together with the U.S. launch of vonoprazan for Erosive GERD, if approved

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets for both VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. VOQUEZNA treatment regimens contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.

https://www.globenewswire.com/news-release/2023/10/30/2769171/0/en/Phathom-Pharmaceuticals-Announces-FDA-Approval-of-Reformulated-Vonoprazan-Tablets-for-VOQUEZNA-TRIPLE-PAK-vonoprazan-amoxicillin-clarithromycin-and-VOQUEZNA-DUAL-PAK-vonoprazan-amo.html