Pfizer (NYSE: PFE) announced on Tuesday that its Phase III studies of Vyndaqel (tafamidis) show the drug significantly reduced mortality and cardiovascular-related hospitalizations compared to placebo over a 30-month period in patients with wild type or variant transthyretin amyloid cardiomyopathy (TAC).
Vyndaqel, which is currently on the market in the European Union for familial amyloid polyneuropathy, was shown by the ATTR-ACT study to reduce mortality risk by around 30% and risk of hospitalizations related to cardiovascular conditions fell by 32% against placebo. The drug also boasted a safety profile similar to that of placebo.
"We believe the ATTR-ACT study findings bring us a significant step closer to our goal of providing an urgently needed therapy for a serious and often fatal disease," said Brenda Cooperstone, senior vice president and chief development officer for rare disease at Pfizer. "We look forward to continuing discussions with global regulatory authorities about the potential of tafamidis as a treatment option for people living with ATTR-CM."
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