US-based Pfizer has met its primary endpoint in the Tafamidis phase three study intended for the treatment of transthyretin cardiomyopathy, it was reported on Monday.
The product demonstrated a statistically significant decrease in the combination of all-cause mortality and frequency of cardiovascular-related hospitalisations compared to placebo at 30 months. The preliminary safety data indicated that the product was generally well tolerated in this population and no new safety signals were identified.
Pfizer's ATTR-ACT study was designed to evaluate clinically meaningful results for the use of the product as a treatment for patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure. ATTR-ACT is a Phase three international, multicentre, double-blind, placebo-controlled, randomised, three-arm clinical study of 441 patients that investigated the efficacy, safety, and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo.
GSK wins European Commission approval for Shingrix prefilled syringe
Tri-City Cardiology adds new members to care team
GENinCode expands Mexico presence with CARDIO inCode-Score distribution agreement
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
InsiteOne agrees strategic partnerships with ASCEND Cardiovascular and Apollo Enterprise Imaging
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
LivaNova secures higher Medicare reimbursement for VNS Therapy procedures