Armetheon And FDA Agree On SPA For Tecarfarin Final Trial

Armetheon has arrived at an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for its oral anticoagulant tecarfarin’s final pivotal trial.

The FDA SPA allows Armetheon to conduct a single, open-label, pivotal trial of 3,000 patients with any indication that requires an OAC, but incorporating only the most responsive patient populations. The FDA has also agreed to allow Armetheon to submit tecarfarin for approval if the trial succeeds in meeting a pre-defined primary endpoint.

According to the company, tecarfarin is positioned to be the only oral anticoagulant (OAC) therapy for patients with prosthetic heart valves (PHV), as specifically identified in the label. The pivotal trial will enroll predominantly patients with all indications for anticoagulation and not just those with PHV. This will support a broad label if the product is approved.

Last month, the American Heart Association (AHA) and the American College of Cardiology (ACC) updated practice guidelines focused on the management of patients with valvular heart disease. The new guidelines state that patients with PHV needing anticoagulation should not use recently approved direct thrombin or Factor Xa inhibitors, but should set their sights on warfarin and possibly tecarfarin.

Tecarfarin is designed to compete with warfarin, the major OAC in the market for all indications. The company said the investigational drug appeared superior to warfarin both in overall population and in the significant percentage of patients with compromised warfarin clearance.

The company said it believes tecarfarin could become the best-in-class vitamin K antagonist versus warfarin. Armetheon also stated that its investigational drug may present fewer complications and allow for a more uniform and predictable response to therapy.

Peter Milner, FACC co-founder and chairman of Armetheon, said, “The key element here is allowing all patients, and in particular the difficult to manage patients with prosthetic heart valves to have a better anticoagulant than any available today. It will be a significant advance in patient care not to have to worry about other drugs or genetics causing problems such as accidental overdoses and to remove the uncertainty that exists when prescribing the currently available oral anticoagulants. We are also particularly grateful for the timelines, clarity and consistency of the FDA's guidance throughout the process.”