Daewoong Pharmaceutical’s Ursa Published in a SCI Journal for Efficacy in the Prevention of Gallstone Formation

Daewoong Pharmaceutical’s Ursa Published in a SCI Journal for Efficacy in the Prevention of Gallstone Formation - Published in JAMA Surgery, an official journal of the American Medical Association - The world's first study that demonstrates the efficacy in the prevention of gallstone formation in patients with gastric cancer who have undergone gastrectomy A clinical trial for Daewoong Pharmaceutical’s flagship product Ursa has been recognized internationally. Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced on June 19 that clinical findings for Ursa’s efficacy in the prevention of gallstone formation have been published in the SCI-level journal JAMA Surgery. JAMA Surgery is an official journal of the American Medical Association (AMA), which has been published since 1920. The study published in this journal is the world's first study that demonstrates the efficacy in the prevention of gallstone formation in patients with gastric cancer who have undergone gastrectomy. Based on the findings of this study, Daewoong obtained indication for Ursa 300 mg for the prevention of gallstone formation after gastrectomy in patients with gastric cancer. The study team divided 521 patients with gastric cancer who have undergone gastrectomy within two weeks into three groups and administered to each group Ursa 300 mg, Ursa 600 mg, and placebo. They compared the incidence of gallstones across the groups over 12 months of continuous administration. The findings showed higher effects on gallstone prevention in the Ursa 300-mg and 600-mg groups than the placebo group. The incidence of gallstones within 12 months was 5.3% (8 out of 151 patients) and 4.3% (7 out of 164 patients) for the Ursa 300-mg and 600-mg groups, which was significantly lower than 16.7% (25 out of 150 patients) for the placebo group. In the Ursa 600-mg group, the incidence of gallstones within 12 months in patients who received D2 dissection, which cut widely the stomach and nearby lymph nodes, was 4.1% (4 out of 97 patients), which was significantly lower than 15.1% in the placebo group (13 out of 86 patients) and confirmed good preventive efficacy on gallstones. Furthermore, nothing in particular was found regarding safety. Do-joong Park, the chief clinical trial coordinator of the study and professor at Seoul National University Hospital’s Department of Gastrointestinal Surgery, said, “Patients who have undergone gastrectomy have the risk of gallstone formation increase while risk also increases during treatment including surgery and endoscopy. Efforts to fundamentally reduce the incidence of gallstones with Ursa is very significant in that it can reduce surgery complications and their risk in gastric cancer patients.” Sang-hyub Lee, a professor at Seoul National University’s Department of Internal Medicine, said, “The incidence of gallstones in gastric cancer patients who have undergone gastrectomy is 13-17% within a year and more than 20% within five years, which is ten times higher than that in other people. Prescribing Ursa to patients who have undergone gastrectomy can not only have a primary preventative effect on gallstone formation, but also ensure safety and cost-effectiveness in the long term.” Sengho Jeon, CEO of Daewoong, said, “As clinical findings for Ursa are published in an internationally authoritative journal, it serves as an opportunity to recognize the value of Ursa more. With continuous R&D, we will do our best effort to contribute to improving the health and quality of life of patients receiving gastric cancer surgery, which happens to more than 20,000 annually.” Meanwhile, Ursa is Korea’s only hepatotonic drug consisting of UDCA (ursodeoxycholic acid) approved by the U.S. Food and Drug Administration (FDA). Clinical trials have been conducted actively, expanding Ursa’s indications to include the liver, pancreas, and biliary tract such as chronic liver disease, secretory failure-induced liver disease, biliary disease, cholelithiasis, chronic hepatitis C, primary biliary cirrhosis, and gallstone prevention in obese patients who experience a rapid weight loss. #   #   # [Photo] Clinical trial on the efficacy in prevention of gallstone formation for Daewoong Pharmaceutical’s Ursa

The release as fetched from its publisher. daewoong.co.kr ↗