FDA, Armetheon Agree on Phase 2 Trial for Anticoagulate

FDA and Armetheon have reached agreement for a single 1,000-patient final pivotal trial for its drug candidate, tecarfarin (Tecarfarin for AntiCoagulation Trial or TACT) prior to filing an NDA, which is expected in 2019. The agency told Armetheon that it can amend an existing Special Protocol Assessment for use with the TACT study, the company says. “Tecarfarin is positioned to potentially be, if approved, the oral anticoagulant therapy of choice for patients who require anticoagulation with a Vitamin K antagonist, such as warfarin,” it says. This includes patients with prosthetic heart valves, repeat deep vein thrombosis and patients with chronic kidney disease, which complicates anticoagulant therapy. The company notes the pivotal trial will enroll patients with all indications for anticoagulation to support a potential broad label if approved.