Mumbai-based Sun Pharmaceutical Industries has launched Fexuprazan tablets 40 mg in India under the brand name Fexuclue, a novel potassium competitive acid blocker (PCAB), that is approved as a new treatment for adults with Erosive Esophagitis of all grades.
Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd, based in Korea, to manufacture and commercialise Fexuclue (Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties.
Fexuprazan 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 Erosive Esophagitis healing by 8 weeks. Fexuprazan was found to be well tolerated in Indian patients.
Erosive esophagitis is considered as a type of gastroesophageal reflux disease (GERD) which is commonly associated with symptoms such as heartburn and regurgitation. The prevalence of GERD in India varies from 7.6% to 30% and erosive esophagitis occurs in almost 9% of GERD patients.
