If the report from the Food and Drug Administration is used as an indicator, Pfizer's (NYSE: PFE) new drug Vyndaqel has a big uphill battle to climb if it hopes to win approval in the United States.
Vyndaqel, which is a drug developed to treat transthyretin familial amyloid polyneuropathy, which is a neurodegenerative disease.
FDA reviewer Devanand Jillapalli said this in a report prepared to be reviewed by the advisory panel, “I recommend a complete response action, based on inadequate evidence of effectiveness.” What that means is it is recommended the drug be rejected.
Pfizer has already been approved in Europe for the drug, but in the U.S. it is believed they haven't performed a strong enough study to substantiate claims the drug works as the company asserts.
In a document prepared for the review panel on Thursday, Pfizer admits the product was developed on a fast-forward basis, although that quick process is in fact allowed and supported by the FDA.
At this stage of the process these are only recommendations, and once the panel reviews and listens to arguments from a variety of sources of input, they will make their recommendations to the FDA, which at that time make the decision to accept or reject the treatment in the U.S.
The disease has no approved treatment in the United States at this time.
Pfizer has been under growing pressure to produce new lines of drugs that are protected by patents as former blockbuster drugs like Lipitor are now competing with generic drug makers.
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