CLINICAL TRIALS PROFILE FOR SAVAYSA

All Clinical Trials for Savaysa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02561897 ↗	EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation	Terminated	Axio Research Corporation	Phase 4	2015-12-01	This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02561897 ↗	EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation	Terminated	Electrophysiology Research Foundation	Phase 4	2015-12-01	This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	Daiichi Sankyo Inc.	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	Daiichi Sankyo, Inc.	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	University of Florida	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02618577 ↗	Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes	Recruiting	Daiichi Sankyo Europe, GmbH	Phase 3	2016-02-01	NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised, multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF. The trial will be conducted in several European countries.

Clinical Trial Conditions for Savaysa

Condition Name

Condition Name for Savaysa
Intervention	Trials
Atrial Fibrillation	6
Anticoagulants and Bleeding Disorders	1
Pulmonary Embolism (PE)	1
Venous Thromboembolism	1

Condition MeSH

Condition MeSH for Savaysa
Intervention	Trials
Atrial Fibrillation	6
Hemorrhage	2
Hemostatic Disorders	1
Coronary Disease	1

Clinical Trial Locations for Savaysa

Trials by Country

Trials by Country for Savaysa
Location	Trials
United States	74
Japan	12
United Kingdom	10
Spain	8
Canada	7

Trials by US State

Trials by US State for Savaysa
Location	Trials
California	4
Florida	4
Illinois	3
New Jersey	3
Washington	3

Clinical Trial Progress for Savaysa

Clinical Trial Phase

Clinical Trial Phase for Savaysa
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Savaysa
Clinical Trial Phase	Trials
Completed	6
Recruiting	4
Terminated	1

Clinical Trial Sponsors for Savaysa

Sponsor Name

Sponsor Name for Savaysa
Sponsor	Trials
Daiichi Sankyo Inc.	3
Daiichi Sankyo, Inc.	3
Chiltern International Inc.	2

Sponsor Type

Sponsor Type for Savaysa
Sponsor	Trials
Other	51
Industry	13

SAVAYSA (Edoxaban Tosylate): Clinical Trials, Market Analysis, and Projections

Introduction

SAVAYSA, marketed by Daiichi Sankyo Inc., is an oral anticoagulant used primarily for the treatment of venous thromboembolism (VTE), which includes deep venous thrombosis (DVT) and pulmonary embolism (PE). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Trial Design and Participants

The efficacy and safety of SAVAYSA were evaluated in a randomized, double-blind, active-controlled Phase 3 clinical trial. This trial involved 8,240 patients with symptomatic VTE, randomized to either SAVAYSA or warfarin. The trial was conducted across 439 sites in 37 countries, including North America, South America, Europe, Asia, Australia, New Zealand, and South Africa[3].

Efficacy Results

The trial demonstrated that SAVAYSA was non-inferior to warfarin in treating VTE. The primary efficacy endpoint was the composite of recurrent DVT, new nonfatal symptomatic PE, and fatal PE during the 12-month study period. SAVAYSA showed comparable efficacy to warfarin in preventing these events[3].

Safety Results

Patients treated with SAVAYSA had significantly fewer bleeding problems compared to those treated with warfarin. This is a crucial finding, as bleeding risk is a significant concern with anticoagulant therapy[3].

Recent Clinical Trials and Findings

Lower Dose Edoxaban in Elderly Patients

A recent analysis published in JAMA Cardiology suggested that a lower dose of edoxaban may be an appropriate option for patients over 80 years old, particularly those with higher bleeding risk or frailty. This study indicated that the lower dose could reduce bleeding without compromising protection against ischemic events[4].

Ongoing and Future Trials

Several ongoing and planned clinical trials are exploring the use of SAVAYSA in different patient populations and conditions. For example, trials are being conducted to evaluate the drug's efficacy and safety in patients with various comorbidities and to identify potential brand extensions and new indications[1].

Market Analysis

Global Anticoagulants Market

The global anticoagulants market is driven by several factors, including the rising prevalence of cardiovascular diseases, growth in the geriatric population, increasing healthcare expenditure, and an escalating number of diabetic and cancer patients. SAVAYSA is one of the key players in this market, alongside other oral anticoagulants like Xarelto, Eliquis, and Pradaxa[2][5].

US Market

In the US, SAVAYSA competes in a robust market dominated by other oral anticoagulants. The US anticoagulants market is analyzed by value and sales of top oral anticoagulant drugs, with SAVAYSA holding a significant share. The market is expected to grow due to the increasing demand for effective anticoagulant therapies[5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the anticoagulants market. While there was an initial surge in demand due to the increased risk of thromboembolic events in COVID-19 patients, the pandemic also disrupted supply chains and clinical trial operations. However, the market has shown resilience and is expected to continue growing as healthcare systems recover[2][5].

Market Projections

Growth Drivers

The market for SAVAYSA is expected to grow driven by several factors:

• Rising Prevalence of Cardiovascular Disease: An increase in cardiovascular diseases globally will drive the demand for anticoagulants.
• Growth in Geriatric Population: The aging population is more prone to VTE, increasing the need for anticoagulant therapies.
• Increasing Healthcare Expenditure: Rising healthcare spending will support the adoption of advanced anticoagulant treatments[2][5].

Challenges

Despite the growth drivers, the market faces challenges such as:

• Bleeding Risk: A significant clinical limitation of anticoagulants is the risk of bleeding, which can impact patient compliance and physician prescribing habits.
• Numerous Clinical Limitations: Other clinical limitations, including interactions with other medications and the need for dose adjustments in certain patient populations, can also affect market growth[2].

Patent and Exclusivity Status

Current Patents and Exclusivity

SAVAYSA is protected by two US patents and one FDA regulatory exclusivity. The earliest date for generic entry is estimated to be March 28, 2028, although this could change due to patent challenges or generic licensing[1].

International Patents

The drug has 101 patent family members in 34 countries, with various expiration dates. These patents play a crucial role in maintaining the exclusivity of SAVAYSA in different markets[1].

Key Takeaways

• Clinical Efficacy: SAVAYSA has been shown to be non-inferior to warfarin in treating VTE, with a lower bleeding risk.
• Market Growth: The global anticoagulants market is expected to grow driven by the rising prevalence of cardiovascular diseases and an aging population.
• Challenges: The market faces challenges such as bleeding risk and clinical limitations.
• Patent Status: SAVAYSA is protected by several patents, with the earliest generic entry date estimated to be March 28, 2028.

FAQs

What is SAVAYSA used for?

SAVAYSA (edoxaban tosylate) is used for the treatment of venous thromboembolism (VTE), which includes deep venous thrombosis (DVT) and pulmonary embolism (PE)[3].

How does SAVAYSA compare to warfarin in clinical trials?

SAVAYSA was shown to be non-inferior to warfarin in treating VTE and had a lower risk of bleeding[3].

What are the key drivers of the global anticoagulants market?

The key drivers include the rising prevalence of cardiovascular diseases, growth in the geriatric population, increasing healthcare expenditure, and an escalating number of diabetic and cancer patients[2][5].

When is the earliest date for generic entry of SAVAYSA?

The earliest date for generic entry of SAVAYSA is estimated to be March 28, 2028, although this could change due to patent challenges or generic licensing[1].

How does the lower dose of SAVAYSA impact elderly patients?

A lower dose of SAVAYSA may reduce bleeding risk without compromising protection against ischemic events in elderly patients, particularly those with higher bleeding risk or frailty[4].

Sources

1. DrugPatentWatch: SAVAYSA Drug Patent Profile.
2. GlobeNewswire: Insights on the Anticoagulants Global Market to 2025.
3. FDA: Drug Trials Snapshot: SAVAYSA (edoxaban) for Treatment of Venous Thromboembolism (VTE).
4. TCTMD: Lower-Dose Edoxaban May Be an Option After Age 80.
5. BusinessWire: Global Anticoagulants Market (2021 to 2025) - Size & Forecast with Impact Analysis of COVID-19.