Pfizer Inc. announced 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 judgement was made on the efficacy or safety of tafamidis as part of the letter.

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