FDA Accepts Phathom Pharmaceuticals' Resubmission for Vonoprazan
12 6월 2023 - 10:04PM
Dow Jones News
By Dean Seal
Phathom Pharmaceuticals said the U.S. Food and Drug
Administration has accepted its resubmission of a new drug
application for vonoprazan as a treatment for erosive
gastroesophageal reflux disease, or GERD.
The gastrointestinal disease-focused biopharmaceutical company
said regulators acknowledged that the refiled application
constituted a complete response to the FDA's complete response
letter from February.
The agency said in February that Phathom needed to provide
additional stability data to demonstrate that levels of an impurity
previously found in vonoprazan will remain at or below the daily
acceptable intake throughout the proposed shelf life of the
product.
Phathom's resubmission contained three months of stability data
for reformulated vonoprazan tablets to support the drug's
commercial shelf life. The company said it will continue to provide
stability data throughout the regulatory review.
The FDA has classified the latest new drug application as a
Class 2 resubmission and set a Prescription Drug User Fee Act goal
date of Nov. 17.
"This significant milestone brings us one step closer to the
approval of a new class of treatment for Erosive GERD representing
the first major innovation to the U.S. GERD market in over 30
years," Chief Executive Terrie Curran said.
Shares advanced 2.4% to $13.30 in premarket trading.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 12, 2023 08:49 ET (12:49 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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