NEW YORK (AP) – Pfizer Inc. said that the Food and Drug Administration has asked the company to run another clinical trial of its neurodegenerative disease drug Vyndaqel.
The FDA wants the drugmaker it to study the effectiveness of Vyndaqel as a treatment for transthyretin familial amyloid polyneuropathy, a potentially fatal genetic condition normally treated with a liver transplant, Pfizer said.
Vyndaqel, or tafamidis, is a pill intended to delay neurological impairment in people with the condition, also known as TTR-FAP. European Union regulators approved the use of Vyndaqel in November, and Pfizer said there are no approved drugs for the condition in the U.S. About 8,000 people have TTR-FAP worldwide.
Date: June 18, 2012
Source: Associated Press