Office of New Drugs directs the Division of Cardiology and Nephrology to work with Ardelyx to develop a label to support the commercialization of XPHOZAH; Ardelyx to resubmit NDA in the first half of 2023
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
Conference call to be held Dec. 29, 2022, at 8:00 AM ET
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH.
In the response letter, OND directed the FDA's Division of Cardiology and Nephrology (DCN) to work with Ardelyx to develop an appropriate label. Ardelyx believes that a label could reflect an indication for patients whose hyperphosphatemia is insufficiently managed on binder therapy. In addition, the letter guided Ardelyx to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx will request this meeting as soon as possible to enable the company to resubmit the NDA in the first half of 2023.
The company will host a conference call on December 29, 2022, at 8:00 AM ET. To participate in the conference call, please call (866) 374-5140 (toll-free) or (404) 400-0571 (toll) and reference call ID number 65128972#. A webcast of the call can also be accessed by visiting the Investor page of the company's website at www.ardelyx.com and will be available on the website for 30 days following the call.
https://finance.yahoo.com/news/fda-grants-appeal-ardelyxs-xphozah-120000977.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.