Daewoong Pharma Wins Approval to Use Fexuclue in H. pylori Eradication Therapy

Daewoong Pharmaceutical said Sunday that South Korea’s Ministry of Food and Drug Safety has approved its gastroesophageal reflux disease drug, Fexuclue Tablets 40 mg (fexuprazan hydrochloride), for use in combination antibiotic therapy to eradicate Helicobacter pylori.

Fexuclue can be taken regardless of meals. With the added indication, its approved uses now include treatment of erosive GERD, improvement of gastric mucosal lesions in acute and chronic gastritis, prevention of nonsteroidal anti-inflammatory drug-induced peptic ulcers, and combination therapy for H. pylori eradication.

H. pylori infection has a high prevalence in South Korea, at about 50%, and is known to contribute to chronic gastritis, gastric ulcers, duodenal ulcers and gastric cancer, prompting recommendations for active eradication treatment.

As resistance to clarithromycin, used in first-line eradication therapy, has increased, demand has grown in clinical practice for a wider range of treatment options, the company said.

Daewoong Pharmaceutical said results from a domestic Phase 3 trial conducted at multiple institutions from February 2024 to April last year showed Fexuclue’s treatment effect was particularly pronounced in patients with clarithromycin resistance.

A company official said the eradication rate for a Fexuclue-based regimen in the clarithromycin-resistant group was 54.76%, about 26 percentage points higher than a lansoprazole-based regimen at 28.57%.