Armetheon, FDA Reach Agreement Prior to New Drug Filing for Tecarfarin

Armetheon, FDA Reach Agreement Prior to New Drug Filing for Tecarfarin

Armetheon and the U.S. Food and Drug Administration (FDA) have reached an agreement for a Phase 3 trial of drug candidate Tecarfarin, prior to a new drug application (NDA) filing projected to take place in 2019. Tecarfarin will be evaluated for the treatment of patients requiring anticoagulation, such as those with chronic kidney disease (CKD).

According to Armetheon, the FDA also indicated the company may amend the existing special protocol assessment (SPA) for the final pivotal “Tecarfarin for AntiCoagulation Trial” (TACT), an open-label study expected to enroll 1,000 patients with any indication for anticoagulation, including prosthetic heart valve (PHV). Including a wide range of patients will further support a potential broad label if the product is approved.

“To reach agreement with the FDA to conduct a 1,000 patient final Phase 3 study prior to a potential NDA filing is unprecedented for an anti-thrombosis/cardiovascular drug,” M. (Ken) Kengatharan, PhD, Armetheon’s president and interim CEO, said in a press release.

“This is because the primary end point for approval is an outcome measure called time in therapeutic range (TTR) of the international normalized ratio (or INR) which indicates how effective anticoagulation is managed in a particular patient,” Kengatharan added.

Tecarfarin could become the oral anticoagulant (OAC) therapy of choice for patients requiring anticoagulation with a vitamin K agonist (VKA) like warfarin – considered the standard of care for decades – like those with prosthetic heart valves (PHV) or with CKD. Warfarin has some limitations, however, as some patients, such as those with CKD, have difficulties achieving stable anticoagulation with this medicine.

In light of this therapeutic need, Tecarfarin is being investigated as an anticoagulant that inhibits vitamin K epoxide reductase (VKOR), an important enzyme in the coagulation system, and avoids CYP450 metabolism and renal elimination.

In previous trials, Tecarfarin improved TTR in chronically anticoagulated patients. The effect of Tecarfarin will be further investigated in this upcoming trial.

Tecarfarin has been studied in about 900 patients, enrolled in 10 different clinical trials. These trials include a prior pivotal trial and a study in CKD patients where Tecarfarin was observed to have potential benefits when compared to warfarin.

“Tecarfarin is an important therapeutic option in the armamentarium of anticoagulants particularly for patients who can’t take a novel oral anticoagulant (or NOAC) and where their only option is warfarin,” said Detlef Albrecht, MD, Armetheon’s chief medical officer and head of drug development.

“Armetheon is grateful to the regulatory agencies for accepting our scientific arguments for a trial design enriched with the subjects who have risk factors for poor anticoagulation control and end points that can be used to seek regulatory approval,” Albrecht added.

Leave a Comment