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Phathom Pharma announces Voquezna label expansion
2024-07-18 23:09
- 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.
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- Phathom a buy at Stifel on new heartburn therapy
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