Sun Pharmaceutical Industries announced that it has launched fexuprazan tablets in India, branded Fexuclue, a novel potassium competitive acid blocker approved as a new treatment for adults with erosive esophagitis of all grades.
By improving the drawbacks of existing proton pump inhibitors, Fexuclue binds to the proton pump without activating gastric acid and quickly and stably inhibits the secretion of gastric acid.
Erosive esophagitis, a condition where the esophagus lining is damaged, is graded ranging from grade A (minimal) to grade D (very severe), based on the size and extent of mucosal breaks. Approximately 30% of patients with typical gastroesophageal reflux disease (GERD) symptoms have endoscopic evidence of erosive esophagitis.
Fexuclue was evaluated in a double-blind, double-dummy, comparative phase 3 study in adult Indian population. The primary efficacy measure was healing of erosive esophagitis which was confirmed endoscopically. The study met its primary endpoint. Over 95% of the patients achieved healing by eight weeks.
Sun Pharma licensed the rights to Fexuclue from Korea-based Daewoong Pharmaceutical to manufacture and commercialize to Fexuclue in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties. Daewoong aims to secure approval for Fexaclue in 30 countries by 2025.