Sun Pharmaceutical Industries Limited has launched Fexuclue (fexuprazan tablets 40 mg) in India, offering a novel treatment approach for adults suffering from erosive esophagitis of all grades. As the world's leading specialty generics company, Sun Pharma has introduced this potassium-competitive acid blocker (PCAB) to address significant unmet needs in the management of this serious gastrointestinal condition.
The company has secured rights from South Korea's Daewoong Pharmaceutical Co Ltd to manufacture and commercialize fexuprazan in India. Under the agreement terms, Daewoong will receive upfront and milestone payments, including royalties.
Clinical Efficacy and Safety Profile
Fexuprazan's approval follows a rigorous double-blind, double-dummy, comparative Phase 3 study conducted specifically in adult Indian patients. The primary efficacy endpoint—endoscopically confirmed healing of erosive esophagitis—was successfully met, with over 95% of patients achieving healing by the 8-week mark. The drug demonstrated a favorable safety profile, being well-tolerated across the study population.
Kirti Ganorkar, CEO of India Business at Sun Pharma, emphasized the significance of this launch: "Erosive esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management. Fexuclue is a best-in-class treatment option with the potential to bridge this gap."
Understanding Erosive Esophagitis
Erosive esophagitis is characterized by inflammation and damage to the esophageal lining, typically presenting as breaks or erosions due to chronic irritation. The most common cause is gastroesophageal reflux disease (GERD), where stomach contents flow back into the esophagus, causing irritation and damage.
In India, GERD prevalence ranges from 7.6% to 30% of the population, with approximately 9% of these patients developing erosive esophagitis. Despite existing medical, endoscopic, and surgical therapies, many patients fail to achieve complete healing and symptom relief, resulting in impaired quality of life.
Market Impact
The introduction of Fexuclue represents a significant advancement in the treatment landscape for erosive esophagitis in India. As a potassium-competitive acid blocker, it offers a different mechanism of action compared to traditional proton pump inhibitors, potentially providing benefits for patients who have not responded adequately to existing therapies.
Despite the promising clinical data and therapeutic potential of Fexuclue, Sun Pharma's shares experienced a decline following the announcement, closing 2.97% lower on the BSE.
About the Companies
Sun Pharmaceutical Industries Limited maintains a strong presence in specialty, generics, and consumer healthcare products. As India's largest pharmaceutical company, it also holds a leading position in the US generic market and in global emerging markets.
Daewoong Pharmaceutical, the originator of fexuprazan, is recognized as one of Korea's leading healthcare companies with significant capabilities in new drug development.
