WASHINGTON, May 22 (Reuters) - U.S. drug reviewers recommended on Tuesday rejecting a Pfizer Inc drug because the data did not prove it worked well in treating a rare neurodegenerative disease.
The U.S. Food and Drug Administration staff reviewed the drug, tafamidis, ahead of an advisory panel of outside experts, which will vote on whether to recommend it for approval on Thursday. The FDA will make a final decision later, taking into account the panel's recommendation.
Tafamidis, which is already approved in Europe under the name Vyndaqel, is meant to treat familial amyloid polyneuropathy, a fatal condition that affects about 8,000 people worldwide, according to Pfizer.
.inode/image/byInode/1/filter/Resize,Jpeg/jpeg_q/90/resize_w/187)
.inode/image/byInode/1/filter/Resize,Jpeg/jpeg_q/90/resize_w/187)
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of the Thomson Reuters Foundation. For more information see our Acceptable Use Policy.
comments powered by Disqus