Daewoong Pharmaceutical announced Thursday that its Fexcluded has obtained regulatory approval as a new drug for gastroesophageal reflux disease (GERD).
The company said the Ministry of Food and Drug Safety has cleared 40 milligrams of the excluded for erosive GERD. It plans to request the fixing of the share of the insurance cover in the price of the excluded drug to begin marketing in the first half of 2022.
Excluded is a potassium-competitive acid blocker (P-CAB) that reversibly blocks the proton pump that secretes stomach acid from the stomach wall as a leading new drug for GERD developed by Daewoong.
The new drug improved symptoms faster and maintained its effects longer than existing proton pump inhibitors (PPIs). It also relieved heartburn from the start of administration and improved conditions in three times as many patients as the esomeprazole group, according to Daewoong.
“Excluded will relieve the pain of many patients with GERD,” said Jeon Seng-ho, CEO of Daewoong Pharmaceutical. “Next year, we will launch and develop the Fexclu tablet to make it the best treatment for GERD in Korea.”
The company has demonstrated the excellence of the Excluded by signing 1.1 trillion won ($ 926 million) of technology transfer contracts so far with its partners in the United States, China, the Middle East and the United States. Central and South America.
With the latest approval, Daewoong will attempt to target the global GERD market worth around 40 trillion won.
In addition, the company is also developing various new pipelines, including enavogliflozin for type 2 diabetes and DWN12088 for pulmonary fibrosis.