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Phathom Pharma announces Voquezna label expansion
2024-07-18 23:09
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- Phathom Pharmaceuticals (NASDAQ:PHAT) announced Thursday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its lead product, vonoprazan, allowing its use for a medical condition characterized by heartburn.
- The latest approval allows vonoprazan’s use for adults with heartburn associated with non-erosive gastroesophageal reflux disease (GERD).
- Non-erosive GERD represents the largest category of GERD, a gastrointestinal condition characterized by a burning sensation in the chest due to stomach acid flowing back into the esophagus.
- The company said that the approval was backed by its PHALCON-NERD-301 study, which reached the primary endpoint, indicating a quick and significant reduction of heartburn with daily vonoprazan treatment.
- The FDA has previously approved Vonoprazan, branded Voquezna, for erosive GERD and as a combination therapy with antibiotics for Helicobacter pylori (H. pylori) infection.
More on Phathom Pharmaceuticals
- Phathom Pharmaceuticals: Time To Deliver Promise Of Voquezna After Frustrating Delays
- Phathom Pharmaceuticals, Inc. (PHAT) Q1 2024 Earnings Call Transcript
- Phathom Pharmaceuticals Non-GAAP EPS of -$1.11 beats by $0.06, revenue of $1.91M misses by $0.23M
- Phathom a buy at Stifel on new heartburn therapy
- Seeking Alpha’s Quant Rating on Phathom Pharmaceuticals
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