HK Inno.N has received approval for a sixth indication for its gastroesophageal reflux disease (GERD) drug, K-Cab (ingredient name: Tegoprazan). With this approval, the company now holds the most indications among potassium-competitive acid blockers (P-CAB) in South Korea.
On July 27, HK Inno.N announced that K-Cab has been approved for the indication of preventing peptic ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).
Expanding indications compared to competing drugs is a key factor for increasing sales.
With the new indication, K-Cab now has a total of six approved uses: treatment of erosive GERD, treatment of non-erosive GERD, treatment of gastric ulcers, antibiotic combination therapy for Helicobacter pylori eradication in patients with peptic ulcers and chronic atrophic gastritis, maintenance therapy after treatment of erosive GERD, and prevention of peptic ulcers (gastric and duodenal) associated with NSAID use.
The clinical trials for the new indication were conducted on patients who were long-term NSAID users. The study evaluated the efficacy and safety of K-Cab 25 mg in combination with the proton pump inhibitor (PPI) Lansoprazole 15 mg for preventing gastric and duodenal ulcers.
In the primary efficacy endpoint, the incidence of gastric and duodenal ulcers after 24 weeks showed that the K-Cab group demonstrated non-inferiority compared to the Lansoprazole group. Additionally, at the 12-week mark, the proportion of participants without heartburn was statistically significantly higher in the K-Cab group compared to those taking Lansoprazole.
The NSAIDs taken by the clinical trial participants included a total of 11 types, confirming optimal prescription flexibility and safety. This included eight non-selective NSAIDs such as Felbamate, Naproxen, and Meloxicam, as well as three COX-2 selective inhibitors, including Celecoxib, all of which were found to be safe for long-term use over 24 weeks.
Since its launch in March 2019, K-Cab has maintained its position as the top prescription drug for peptic ulcers in South Korea, based on its rapid onset of action and long-term safety profile. In April, it became the first domestically developed single new drug to surpass 1 trillion won in cumulative prescription sales.
Internationally, K-Cab has secured technology export or finished product export contracts in 55 countries and is currently sold in 20 countries, including South Korea, China, and Latin America. In January of this year, HK Inno.N's U.S. partner, Sebela Pharmaceuticals, submitted a new drug application to the U.S. Food and Drug Administration (FDA), paving the way for entry into the largest global market.
HK Inno.N CEO Kwak Dal-won stated, "Managing gastrointestinal side effects from long-term use of anti-inflammatory drugs is a global unmet need. With the clinical data secured from this new indication, we will strengthen our competitiveness in both the domestic and global markets."
* This article has been translated by AI.
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