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EMA advices Armetheon to conduct single 1000 patients study for tecarfarin prior to MAA filing

Menio Park, California
Thursday, February 16, 2017, 17:00 Hrs  [IST]

Armetheon, a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, has announced that it has received advice from the European Medicines Agency (EMA) Scientific Advice Working Group (SAWG) for the development of its novel oral anticoagulant tecarfarin. The SAWG advised that Armetheon can conduct a single1000 patient pivotal study prior to filing the Market Authorization Application (MAA) for tecarfarin. If approved, tecarfarin is positioned to potentially be the oral anticoagulant (OAC) therapy of choice for patients who require anticoagulation with a vitamin K antagonist (VKA), such as warfarin. This includes patients with prosthetic heart valves (PHV), repeat deep vein thrombosis or patients with chronic kidney disease (CKD) which complicates anticoagulant therapy. This pivotal trial will enroll patients with all indications for anticoagulation, thereby supporting a potential broad label if the product is approved.

Despite warfarin being the standard of care OAC for decades, physicians recognize its limitations related to its metabolism via cytochrome P450 (CYP). Patients who take a CYP interacting drug have variant CYP2C9 genetics or CKD face significant challenges achieving stable anticoagulation control with warfarin. The planned 1000 patient Phase 3 study will specifically enroll patients with these challenges to demonstrate tecarfarin’s ability to provide improved anticoagulation control compared to warfarin. There are at least 15 conditions requiring OAC therapy where a VKA such as warfarin is predominantly used.

“The advice received from the EMA-SAWG for the conduct of a single 1000 patient final phase 3 study prior to a potential MAA filing allows for a global harmonization of our development plan for tecarfarin”, said Armetheon’s president & interim chief executive officer, M. (Ken) Kengatharan, PhD. “The primary end point for approval is time in therapeutic range (TTR) of the international normalized ratio (or INR), an outcome measure, which indicates how effectively anticoagulation is managed in a particular patient receiving a VKA and has now been accepted by the EMA, FDA and the PMDA.”

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

“Tecarfarin is an important therapeutic option for patients with indications requiring an oral anticoagulant where only warfarin can be used and who can’t take a novel oral anticoagulant (NOAC) such as a Factor Xa or a thrombin inhibitor,” commented Detlef Albrecht, MD, Armetheon’s chief medical officer and head of drug development. “We are grateful to the major regulatory agencies, US FDA, Japan’s PMDA and now the EMA 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 without the need for clinical outcome studies.”

 

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