FDA Drug Reviewers Advise Against Approval of Pfizer’s Tafamadis

Posted on May 22, 2012

A pill designed by Pfizer to help those with a certain deadly medical condition is facing an advisory panel composed of outside experts on Thursday, and in the lead-up, the pill already has one strike against it.

Drug reviewers from the Food and Drug Administration have advised not approving the drug known as tafamidis.  That’s not the end of the line, though.  As mentioned, the pill will be reviewed by a panel on Thursday.  That panel will make its own recommendation on what to do to the FDA, who will then take time to decide the final outcome.

Tafamidis is used to combat a fatal disease known as familial amyloid polyneuropathy.  About 2,500 people suffer from this throughout the country, with an additional 7,500 throughout the world.  Right now, liver transplants are the only treatment.

Although Tafamidis is available under the name Vyndaqel throughout Europe, reviewers with the FDA hesitated to recommend the product on American shores.  They said that a clinical trial didn’t show unequivocally that the product helps people with the disease anywhere but Portugal, where the drug was most successful.  And even in that instance it wasn’t made clear why that country had such success.  The reviewers also questioned the reliability of clinical trials in which the group given the drug had what they say was a milder form of the condition than did the group who took a placebo.

Only time will tell if the FDA ends up approving the drug.

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