ARTICLE | Clinical News

Tafamidis: Extension study data

April 25, 2011 7:00 AM UTC

Data from 86 patients with a V30M mutation in the TTR gene in the 12-month, open-label Fx-006 extension of the double-blind, international Phase II/III Fx-005 trial showed that patients treated with tafamidis for 30 months had significantly less neurologic deterioration as measured by mean change from baseline in NIS-LL score vs. patients who received placebo for 18 months followed by tafamidis for 12 months (3 vs. 6.8 points, p=0.04). Data were presented at the American Academy of Neurology meeting in Honolulu. Pfizer previously reported preliminary data from the Fx-005 trial in 128 patients showing that tafamidis missed the co-primary endpoints of significantly improving disease progression and quality of life at 18 months vs. placebo (see BioCentury, July 27, 2009). ...