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FDA refuses to file Pfizer NDA

The US Food and Drug Administration has refused to accept Pfizer's new drug application for a potential treatment for a rare, progressively fatal genetic neurodegenerative disease

The US Food and Drug Administration has refused to accept for filing Pfizer's new drug application for a potential treatment for transthyretin familial amyloid polyneuropathy, a rare, progressively fatal genetic neurodegenerative disease for which liver transplant is the only treatment option that is currently available.

Pfizer submitted the application for the drug, an oral compound called tafamidis, in February of this year. The FDA said it had determined after a preliminary review that the application was not sufficiently complete to permit a substantive review. The FDA has not yet made any determination about the efficacy or safety of tafamidis, Pfizer stressed.

Pfizer said that it is working with the FDA to resubmit the application as soon as possible, and that it does not believe additional clinical trials will be needed in order to complete the submission.

Pfizer acquired tafamidis in late 2010, when it bought the privately held drug discovery and development company FoldRx Pharmaceuticals for an undisclosed sum. FoldRx is focused on investigational compounds to treat diseases caused by protein misfolding, a recognised underlying cause in many chronic degenerative diseases.

FoldRx has filed a marketing authorisation application with the European Medicines Agency (EMA) for tafamidis, which has orphan drug designation in both the US and European Union (EU) and Fast Track designation in the US.

5th April 2011

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