(Health Korea News / Ji-in Yoo) As the U.S. Food and Drug Administration (FDA) additionally approved Phathom Pharmaceuticals’ potassium-competitive acid inhibitor (P-CAB) ‘Voquezna (ingredient: vonoprazan)’ as a non-erosive gastroesophageal reflux disease (GERD) treatment on the 18th (local time), domestic P-CAB drugs are also expected to benefit. ‘Voquezna’ is a product of Japan’s Takeda Pharmaceutical Company and is also called ‘Vocinti’ (ingredient: vonoprazan) depending on the region.
This approval marks the third indication recognized by the FDA. Boquezna was previously approved as an antibiotic combination therapy for moderate erosive gastroesophageal reflux disease and eradication of Helicobacter pylori.
In relation to this, the securities industry predicted that domestic P-CAB formulation companies such as HK inno.N and Daewoong Pharmaceutical would gain momentum in entering the U.S. market.
In a recent corporate analysis report, Kiwoom Securities researcher Shin Min-soo predicted, “If a competitor develops the market first, HK inno.N can quickly penetrate the market by emphasizing cost-effectiveness through attractive drug price settings,” adding, “If the expansion of the indications for ‘Voquezna’ is successful, the possibility of HK inno.N’s successful entry into the U.S. market for ‘K-Cap (ingredient name: tegoprazan)’, a treatment for gastroesophageal reflux disease, will increase.”
Ha Hyun-soo, a researcher at Yuanta Securities, also said, “Bokezna is the only P-CAB drug sold in the U.S. market and is showing a solid monthly prescription performance increase trend,” and predicted, “The increased prescription preference for P-CAB drugs (in the U.S.) will lead to rapid market penetration after the launch of K-Cap in the future.”
Daewoong Pharmaceutical is also expected to benefit.
Daewoong Pharmaceutical’s P-CAB gastroesophageal reflux disease treatment drug ‘Fexuclu (ingredient name: Fexuprazan)’ garnered much attention with the research results presented as a poster at ‘Digestive Disease Week 2024 (DDW)’ held in Washington D.C., USA in May.
According to the research results announced at the time, Pexuprazan was effective in preventing damage to the small intestinal mucosa caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It was also confirmed to have an anti-inflammatory effect by inhibiting the pyroptosis pathway, a type of inflammatory cell death in esophageal cells. In addition, the anti-inflammatory potential of Pexuprazan for gastric inflammation caused by cytotoxic genes after Helicobacter pylori infection was also proven.
HK inno.N and Daewoong Pharmaceutical are currently actively conducting clinical research for entry into the U.S. market.
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