By Balaji
SridharanMay 25, 2012 8:49 AM EDT (Reuters) - A U.S. health advisory panel on
Thursday issued a split vote on data for Pfizer Inc's drug to treat a rare
neurodegenerative disease. The U.S. Food
and Drug Administration panel voted 13 to 4 that the drug did not show that it
met the main goal in a study in treating the fatal condition. However, the
panel also voted 13 to 4 that the drug treated a surrogate endpoint, which may
correlate with treating the underlying disease.The panel's recommendation will
be considered by the U.S. Food and Drug Administration when it takes a decision
on tafamidis, a relatively minor product for the world's largest drugmaker.FDA
staff on Tuesday recommended rejecting the drug saying the data did not prove
that it worked well in treating the disease.Tafamidis, which is already
approved in Europe under the name Vyndaqel, is
meant to treat familial amyloid polyneuropathy, a fatal condition that affects
as many as 10,000 people worldwide, including about 2,500 Americans.
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