HK inno.N(195940)'s gastroesophageal reflux disease treatment "K-CAB" expanded its prescribing scope by adding an indication to prevent gastric ulcers in patients who take painkillers for a long time.
HK inno.N said on the 27th that it received additional approval from the Ministery of Food and Drug Safety for K-CAB (ingredient name tegoprazan) for the indication of "prevention of peptic ulcers related to administration of nonsteroidal anti-inflammatory drugs (NSAIDs)."
NSAIDs are anti-inflammatory analgesics widely used for arthritis and musculoskeletal pain. Long-term use increases the risk of ulcers in the stomach and duodenum, so medications that suppress gastric acid secretion are often prescribed together.
With this approval, K-CAB has secured six indications in total: ▲ erosive gastroesophageal reflux disease ▲ nonerosive gastroesophageal reflux disease ▲ gastric ulcer ▲ Helicobacter pylori eradication therapy ▲ maintenance therapy for reflux esophagitis, and now prevention of gastric ulcers in patients taking painkillers.
The approval was based on clinical trial results in patients taking NSAIDs long term. In the study, K-CAB 25 mg was compared with lansoprazole, an existing proton pump inhibitor (PPI), and demonstrated noninferiority in preventing gastric and duodenal ulcers over 24 weeks. At 12 weeks, the proportion of patients without heartburn symptoms was significantly higher than with lansoprazole.
K-CAB is a P-CAB (potassium-competitive acid blocker) therapy characterized by rapid suppression of gastric acid secretion. In the current market for acid-suppressing therapies, existing PPI (proton pump inhibitor) drugs are used the most, and K-CAB is expanding the market as a next-generation acid suppressant.
Launched in 2019, K-CAB is Korea's 30th homegrown new drug, and in Apr. it became the first single domestic new drug product to surpass 1 trillion won in cumulative outpatient prescriptions. It has signed technology export or finished goods supply contracts with 55 countries and is being sold in 20 countries, including Korea, China, and Latin America.
In the United States, partner Sevela Pharmaceuticals filed a new drug application with the Food and Drug Administration (FDA) in Jan., and the review is underway.