Introduction to EDARBYCLOR
EDARBYCLOR is a fixed-dose combination medication that combines azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a thiazide-like diuretic. It is specifically designed to treat hypertension in adults, aiming to lower blood pressure and reduce the risk of associated cardiovascular events[1][3].
Clinical Trials and Efficacy
Approval and Clinical Program
EDARBYCLOR was approved by the U.S. Food and Drug Administration (FDA) in December 2011, following a comprehensive clinical program that included five phase 3 clinical studies involving over 5,000 patients with hypertension. These studies ranged from 8 to 52 weeks in duration and evaluated the safety and efficacy of EDARBYCLOR at various doses (20/12.5 mg to 80/25 mg once daily)[1].
Superior Blood Pressure Control
Clinical trials demonstrated that EDARBYCLOR provided statistically significant blood pressure reductions compared to its respective monotherapies and was superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide (Benicar HCT) at maximum respective doses. Specifically, EDARBYCLOR achieved a 14.5% greater reduction in systolic blood pressure compared to Benicar HCT[1][3].
Effectiveness in Diverse Patient Populations
EDARBYCLOR has shown effectiveness across multiple patient populations, including African American patients, who often have a less active renin-angiotensin system (RAS). In this subgroup, EDARBYCLOR provided an 18% greater systolic blood pressure reduction compared to Benicar HCT[1][3].
Safety and Tolerability
The safety of EDARBYCLOR was evaluated in more than 3,900 patients. The medication was found to be generally well-tolerated, with side effects being mild and transient. Patients may require monitoring of potassium and creatinine levels while taking the medication. Incidence of consecutive elevations of creatinine was noted but was typically transient and reversible[3][4].
Market Analysis
Market Size and Growth
The market for EDARBYCLOR is part of the broader hypertension treatment market, which is expected to grow significantly due to the increasing prevalence of hypertension and other cardiovascular diseases. The Edarbi market, which includes EDARBYCLOR, is projected to expand at a considerable growth rate from 2022 to 2028. This growth is driven by factors such as increasing awareness about hypertension, the importance of early diagnosis, and growing spending on chronic diseases[2].
Key Market Drivers
- Increasing Prevalence of Hypertension: The rising number of patients with hypertension globally is a significant driver for the EDARBYCLOR market.
- Research and Development: Continuous investment in research and development by key players is leading to the creation of technologically advanced products, boosting market growth.
- Market Penetration: Efforts to increase market penetration, especially in developing regions, offer lucrative growth opportunities despite challenges such as limited awareness and high costs[2].
Market Challenges
- High Cost: The cost of EDARBYCLOR is a significant barrier, with a 30-tablet supply costing around $266, which is substantial for many patients.
- Limited Awareness: In some regions, particularly developing countries, there is limited awareness about hypertension and available treatments, restricting the adoption of EDARBYCLOR.
- Insurance and Economic Factors: The lack of favorable insurance systems and low economic conditions in some areas further hinder the widespread adoption of EDARBYCLOR[2].
Market Projections
Future Growth
The hypertension treatment market, including EDARBYCLOR, is expected to see significant growth driven by the increasing prevalence of hypertension and the need for effective treatments. The Edarbi market, which includes EDARBYCLOR, is projected to expand considerably from 2022 to 2028, driven by increasing awareness, early diagnosis, and growing healthcare spending[2].
Licensing and Distribution
EDARBYCLOR is marketed and sold in the United States by Arbor Pharmaceuticals under a licensing agreement with Takeda Pharmaceuticals. This agreement provides Arbor with exclusive rights to promote and sell EDARBYCLOR, while Takeda receives upfront payments and future milestone and royalty payments based on sales[4].
Key Takeaways
- Efficacy: EDARBYCLOR has demonstrated superior blood pressure control compared to similar medications.
- Market Growth: The market for EDARBYCLOR is expected to grow due to the increasing prevalence of hypertension and ongoing research and development.
- Pricing: The current cost of EDARBYCLOR is around $266 for a 30-tablet supply, with no generic version available.
- Distribution: EDARBYCLOR is marketed and sold in the U.S. by Arbor Pharmaceuticals under a licensing agreement with Takeda.
FAQs
What is EDARBYCLOR used for?
EDARBYCLOR is used for the treatment of hypertension in adults to lower blood pressure. It can be used as an initial therapy or in patients not adequately controlled with monotherapy[2].
How does EDARBYCLOR compare to other hypertension medications?
EDARBYCLOR has demonstrated statistically superior blood pressure control compared to Benicar HCT in clinical studies, especially in African American patients[1][3].
What are the common side effects of EDARBYCLOR?
Clinical studies have shown that the side effects of EDARBYCLOR are generally mild and transient. Patients may need monitoring of potassium and creatinine levels while taking the medication[3].
Is EDARBYCLOR available as a generic?
No, EDARBYCLOR is currently available only as a brand name drug, and a generic version is not yet available[2].
Who markets and sells EDARBYCLOR in the United States?
EDARBYCLOR is marketed and sold in the United States by Arbor Pharmaceuticals under a licensing agreement with Takeda Pharmaceuticals[4].
Conclusion
EDARBYCLOR represents a significant advancement in the treatment of hypertension, offering a potent combination of an ARB and a diuretic that has demonstrated superior efficacy in clinical trials. Despite market challenges such as high costs and limited awareness, the market for EDARBYCLOR is projected to grow substantially, driven by increasing prevalence and awareness of hypertension.
"Hypertension is a complex disease that affects one in three Americans. It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack," - Domenic Sica, M.D., professor of internal medicine and nephrology at Virginia Commonwealth University Medical Center[1].
Sources
- Takeda Pharmaceutical Company Limited. "FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension." December 20, 2011.
- DrugPatentWatch. "Pharmaceutical drug prices and trends for EDARBYCLOR."
- Arbor Pharmaceuticals. "EDARBYCLOR® (azilsartan medoxomil/chlorthalidone) Efficacy."
- Takeda Pharmaceuticals. "Takeda and Arbor Announce a Licensing Agreement for EDARBI and EDARBYCLOR." September 11, 2013.
- FDA. "202331Orig1s000 - accessdata.fda.gov." December 20, 2011.
