Real World ETNA Registries of New Once-Daily LIXIANA® (edoxaban) Start in Europe (1)

Publicado 24/08/2015 7:00:52CET

MUNICH, August 24, 2015 /PRNewswire/ --

FOR EU MEDIA ONLY. NOT FOR UK MEDIA.

- Daiichi Sankyo announces enrollment of first patient in ETNA-AF-Europe and the

commencement of ETNA-VTE-Europe, two regional registries to collect robust information

on how once-daily LIXIANA(R) is being used in real world settings  

- ETNA is a Daiichi Sankyo global initiative which will collect data from approximately

30,000 patients taking edoxaban during a follow-up period of up to four years  

- LIXIANA(R) is an oral, once-daily, factor Xa-inhibitor, that is licensed in Europe for

stroke prevention in NVAF and for the treatment and prevention of recurrent DVT and

PE 

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) announced that the first patient has been enrolled in ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice - Atrial Fibrillation - Europe), as well as the commencement of ETNA-VTE-Europe (Edoxaban Treatment in routiNe clinical prActice - Venous ThromboEmbolism - Europe).

The European ETNA registries are part of the global ETNA initiative which is comprised of regional patient registries designed to reflect regional needs and local clinical practice. The objective of ETNA is to collect a robust set of information on how once-daily LIXIANA(R) (edoxaban) is being used in real world settings. This will include safety and efficacy parameters as well as other important data that can help to guide best use of once-daily LIXIANA(R). In Europe, ETNA will be conducted across 12 countries and will collect data from up to 15,700 patients.

"ETNA will provide important information on how this new once-daily oral anticoagulant is being used in patients in real world settings," said Dr. Juan-Carlos Jaramillo, Head of Market Access and Medical Affairs at Daiichi Sankyo Europe GmbH. "Daiichi Sankyo is investing in the late phase programme for edoxaban to answer customer's question on the use of LIXIANA(R) (edoxaban), and ETNA is an exciting opportunity to provide further information enabling healthcare systems to make best use of this important medicine."

In Europe, the two non-interventional ETNA registries are being conducted in patients who are already receiving once-daily LIXIANA(R) for its licenced indications. In ETNA-AF-Europe, data from approximately 13,000 patients will be collected from 1,450 sites across 12 countries. In ETNA-VTE-Europe, data from approximately 2,700 patients will be collected from 660 sites, across 11 European countries.  

In June 2015 the European Commission (EC) granted Marketing Authorisation for LIXIANA (R), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

In the ENGAGE AF-TIMI 48 study, once-daily LIXIANA(R) showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA(R) 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety and significantly reduced major bleeding (2.75% vs. 3.43% per year, LIXIANA(R) 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.[1]

The Hokusai-VTE study demonstrated that once-daily LIXIANA(R) effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, LIXIANA(R) 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). Once-daily LIXIANA(R) also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).[2]

About ETNA-AF-Europe 

ETNA-AF-Europe is a non-interventional post-authorization safety study (PASS). It will enroll 13,100 patients from 1,450 sites across 12 countries in Western Europe. The study will follow patients taking once-daily LIXIANA(R) for NVAF for up to four years. The primary objective of ETNA-AF-Europe is to collect real world safety data on bleeding events including intracranial hemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality in NVAF patients treated with once-daily LIXIANA(R). Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.    

Secondary objectives include assessing the effect of once-daily LIXIANA(R) on patient relevant outcomes such as stroke, systemic embolic events, major CV events and hospitalizations related to CV condition. ETNA-AF-Europe will also collect real world data on a range of additional measures including Resource Utilization and Patient Reported Outcomes (PRO) data as well as useful elements such as the Montreal Cognitive Assessment (MoCA).

About ETNA-VTE-Europe 

ETNA-VTE-Europe is a registry which will examine real world use of once-daily LIXIANA (R) in patients with acute VTE i.e. DVT and PE. The primary objective is the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. The co-primary objective of this study is to collect real world safety data on bleeding events, other relevant drug related adverse events, and mortality (VTE-related and all-cause). Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.

Secondary objectives include assessing the effect of once-daily LIXIANA(R) on patient relevant outcomes such as major CV events and hospitalizations related to CV condition.

ETNA-VTE-Europe will also collect real world data on a range of additional measures including Resource Utilization and PRO data as well as useful elements such as post-thrombotic syndrome (PTS).

About LIXIANA(R) (edoxaban)

Once-daily LIXIANA(R) was developed solely by Daiichi Sankyo. It received EU approval in June 2015 for the prevention of stroke and SE in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or TIA as well as for the treatment of DVT and PE, and prevention of recurrent DVT and PE in adults. It has launched in the United Kingdom and Germany with further European launches planned for 2015.

LIXIANA(R) was launched in Switzerland in May 2015 for the prevention of stroke and SE in adult patients with NVAF, and for the treatment of adult patients with VTE, including DVT and PE, following previous treatment with fractionated or unfractionated heparin for five days, as well as for the prevention of recurrent VTE.[3] In addition, edoxaban is currently marketed in Japan and the United States.[4],[5],[6] In other countries, regulatory review is ongoing.

About AF and VTE 

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