Pfizer Inc. : FDA Reviewer Recommends Against Approval Of Pfizer Drug

05/22/2012| 11:13am US/Eastern

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   By Jennifer Corbett Dooren 
   Of  
 

A Food and Drug Administration medical reviewer recommended the agency not approve a drug developed by a Pfizer Inc. (>> Pfizer Inc.) subsidiary to treat a rare genetic disorder that affects the nervous system because there's "inadequate" evidence the drug works.

Pfizer subsidiary FoldRx is seeking FDA approval of a drug called tafamidis to treat an inherited condition called transthyretin familial amyloid polyneuropathy.

The disease, believed to affect 8,000 people world-wide, is caused by a defect in the TTR gene that causes abnormal proteins to build up and form amyloid fibrilis, which is deposited in the nervous system and elsewhere.

Tafamidis will be reviewed Thursday by a panel of non-FDA medical experts. The FDA released a review of tafamidis Tuesday in preparation for the meeting. The drug has a proposed brand name of Vyndaqel and was approved in Europe last year.

An FDA medical reviewer recommended the agency issue a so-called complete response letter for tafamidis because the clinical study submitted in support of the drug didn't meet a primary goal that included a measure of differences in muscle weakness and reflexes between patients treated with the drug and those who didn't receive the drug. Complete response letters essentially mean the FDA rejects a drug until companies address problems outlined in the letter such as a need for more clinical data. The tafamidis study did meet some secondary effectiveness goals, the FDA said.

An agency division head said in a memo that the FDA hasn't made a final decision on tafamidis and wants the panel to discuss whether the data submitted by Pfizer could support approval.

 
   -By Jennifer Corbett Dooren, Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com 
 
 

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