VyndaqelTreatment for Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy
Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Application
NEW YORK--(BUSINESS WIRE)--Apr 4, 2011 - Pfizer Inc. (NYSE: PFE) announced today that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for tafamidis, the company's novel, oral investigational compound for patients with Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).
Upon preliminary review, the FDA determined that the application, which was submitted in February 2011, was not sufficiently complete to permit a substantive review. The company believes that the additional information needed to support this filing is available without further clinical studies. Pfizer is currently working closely with the FDA to resubmit the application as quickly as possible. A Refusal to File letter does not provide comment on the acceptability of the clinical data, and no judgment was made on the efficacy or safety of tafamidis as part of the letter.
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DISCLOSURE NOTICE: The information contained in this release is as of April 4, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about a product candidate, tafamidis, including its potential benefits and the anticipated resubmission of a new drug application with the FDA including additional information that is available without further clinical studies. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when the Company will resubmit a new drug application for tafamidis with the FDA, and whether and when the FDA will accept any such resubmission based on additional information that is available without further clinical studies; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tafamidis as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.
Posted: April 2011
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- FDA Advisory Committee Finds Data Support Effectiveness of Tafamidis Meglumine, Pfizer's Novel Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) - May 25, 2012
- FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) - February 15, 2012