HK inno.N has submitted a brand new drug software (NDA) for its gastroesophageal reflux illness (GERD) drug Ok-CAB (energetic ingredient: tegoprazan) to the U.S. Meals and Drug Administration (FDA).
The corporate introduced on Jan. 13 that Braintree, a gastrointestinal specialty firm below its U.S. accomplice Sebela Prescription drugs, submitted an NDA for Ok-CAB to the FDA on Jan. 9 (native time). This software goals for simultaneous approval of three indications: non-erosive reflux illness (NERD), erosive esophagitis (EE) remedy, and upkeep remedy following erosive esophagitis remedy.
The idea for the approval software is the Section 3 medical trial TRIUMpH Program performed on U.S. sufferers. Greater than 2,000 sufferers participated on this medical trial, together with 1,250 sufferers with erosive esophagitis and 800 sufferers with non-erosive gastroesophageal reflux illness. The trial was performed in a multicenter, double-blind method.
Within the erosive esophagitis medical trial, tegoprazan was in contrast with lansoprazole, a PPI-class drug, to judge preliminary therapeutic results and 24-week upkeep remedy results. The outcomes confirmed results equal to or superior to present therapies, and in extreme affected person teams (LA grades C and D), statistically important superiority was demonstrated at each 2-week and 8-week time factors. Within the non-erosive gastroesophageal reflux illness medical trial, tegoprazan was in contrast with placebo for 4 weeks, and important enchancment results in comparison with placebo have been confirmed in key indicators, together with the proportion of days with out 24-hour heartburn.
Gastroesophageal reflux illness is a continual situation that causes heartburn and acid reflux disorder signs when abdomen contents move again into the esophagus. The variety of sufferers in the USA is estimated at 65 million. Ok-CAB is a P-CAB class drug that instantly blocks gastric acid secretion with no need to be activated by gastric acid, not like present PPIs. Presently, know-how export or completed pharmaceutical export contracts have been signed with 56 international locations worldwide, and it has obtained approval in 22 international locations and been launched in 19 international locations. Since its 2019 launch, cumulative home outpatient prescription gross sales by way of final 12 months recorded 923.3 billion gained.
Kwak Dal-won, CEO of HK inno.N, said, “As a world best-in-class product main the world market, we are going to actively pursue European exports and Japanese growth as effectively.”
