US FDA agrees to 1000-patient pivotal trial of Armetheon’s tecarfarin

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Armetheon has reached agreement with the US Food and Drug Administration (FDA) for a single 1000-patient final pivotal trial for its drug candidate, tecarfarin (Tecarfarin for Anticoagulation Trial, TACT) prior to filing an New Drug Application, which is currently projected to occur in 2019. 

Further, the agency indicated that Armetheon can amend the existing Special Protocol Assessment for the 1000-patient TACT study. 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. The pivotal trial will enrol patients with all indications for anticoagulation, thereby supporting a potential broad label if the product is approved.

Despite warfarin being the standard-of-care oral anticoagulant therapy for decades, it is limited in relation to its metabolism via cytochrome P450 (CYP). Patients who take a CYP interacting drug, have variant CYP2C9 genetics or chronic kidney disease have significant challenges to achieve stable anticoagulation control with warfarin.

The TACT study will specifically enrol patients with these challenges to demonstrate tecarfarin’s ability to provide improved anticoagulation control compared to warfarin. There are at least 15 conditions requiring oral anticoagulant therapy where a vitamin K antagonist such as warfarin is predominantly used, representing at least 1.7 million patients in the USA alone, with 91% of these patients taking at least one CYP-interacting drug.

In a prior interaction with Japan’s Pharmaceuticals and Medical Device Agency, Armetheon has received regulatory guidance for the development toward the Marketing Authorization Application for tecarfarin in Japan.

Tecarfarin has been studied in close to 900 patients in 10 different clinical trials, including a prior pivotal trial and a study in chronic kidney disease patients, where tecarfarin was observed to have potential benefits based on pharmacokinetics when compared to warfarin.