Velphoro: Clinical Trials, Market Analysis, and Projections
Introduction to Velphoro
Velphoro, also known as sucroferric oxyhydroxide, is a calcium-free phosphate binder used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Developed by Vifor Fresenius Medical Care Renal Pharma (VFMCRP), Velphoro has been gaining traction globally due to its efficacy and safety profile.
Clinical Trials Update
Phase III Clinical Trial in China
A significant milestone for Velphoro was the positive results from the phase III clinical trial conducted in China, known as the PA-CL-CHINA-01 study. This open-label, active-controlled, parallel group, multicenter study involved 286 patients, with 142 in the Velphoro arm and 144 in the sevelamer carbonate arm. The study demonstrated that Velphoro met its primary efficacy endpoint of non-inferiority versus sevelamer carbonate in lowering and maintaining serum phosphorus levels after 12 weeks of treatment[1].
Key findings from the study include:
- Faster decline in serum phosphorus levels in patients treated with Velphoro compared to those in the sevelamer group.
- Lower average number of tablets taken daily by patients on Velphoro (3.23) versus sevelamer carbonate (6.31).
- Consistent safety profile with no new safety signals observed in Chinese CKD patients with hyperphosphatemia.
Other Clinical Trials
Velphoro has been involved in various clinical trials globally. For instance, it is under development for the control of serum phosphorus levels in pediatric patients 2 years of age and older with CKD on dialysis in the EU. Additionally, there are ongoing phase 2 and phase 4 trials sponsored by different institutions, including the University of Colorado and Vifor Fresenius Medical Care Renal Pharma[2][3].
Market Analysis
Current Market Position
Velphoro has established itself as a significant player in the calcium-free phosphate binder market. The drug's approval and positive clinical trial results have strengthened its position globally. In China, the positive phase III trial results are expected to support market expansion, with a submission to the Chinese Center for Drug Evaluation (CDE) anticipated[1].
Market Size and Growth
The hyperphosphatemia treatment market, which includes Velphoro, is projected to grow significantly. The market is expected to reach USD 3.80 billion in 2024 and grow at a CAGR of 3.67% to reach USD 4.55 billion by 2029. This growth is driven by the increasing prevalence of chronic kidney disease and supportive reimbursement policies[5].
Regional Expansion
Velphoro's market presence is expanding regionally. For example, in the United States, the FDA broadened the approval for Velphoro to include individuals aged nine and older undergoing dialysis. Similarly, in Canada, Health Canada approved a lifetime reimbursement for Velphoro, which is expected to boost adoption rates[5].
Projections and Future Outlook
Patent Exclusivity and Generic Entry
Velphoro is protected by several patents, with the earliest date for generic entry estimated to be July 23, 2030. However, this date may change due to patent challenges or generic licensing. The strong interest in generic launch, as indicated by six patent litigation cases, suggests that generic competition could arise sooner if patent challenges are successful[2].
Market Drivers
Several factors are driving the growth of Velphoro in the market:
- Increasing Prevalence of CKD: The rising number of patients with chronic kidney disease is a significant driver.
- Regulatory Approvals: Broadened approvals and new market entries, such as in China, are expanding Velphoro's reach.
- Reimbursement Policies: Government-backed reimbursement benefits, like those in Ontario, Canada, are expected to enhance adoption rates[5].
Challenges
Despite the positive outlook, the market may face challenges:
- Potential Side Effects: Approved medications for hyperphosphatemia, including Velphoro, may have side effects that could impact market growth.
- Competition: The entry of generic versions, if patents are successfully challenged, could introduce competition and affect market share[5].
Safety and Efficacy Profile
Safety Profile
Clinical trials have consistently shown that Velphoro has a safe profile. The PA-CL-CHINA-01 study confirmed the known safety profile of Velphoro with no new safety signals observed in Chinese CKD patients. Adverse events related to bone fractures and cardiovascular events were minimal and comparable to the sevelamer group[1][4].
Efficacy Profile
Velphoro has demonstrated efficacy in lowering and maintaining serum phosphorus levels. The drug's ability to achieve this with a lower number of tablets compared to sevelamer carbonate is a significant advantage. This efficacy, combined with its safety profile, makes Velphoro an important treatment option for patients with hyperphosphatemia on dialysis[1][3].
Key Takeaways
- Clinical Trials: Velphoro has shown positive results in phase III clinical trials, including the PA-CL-CHINA-01 study, demonstrating non-inferiority to sevelamer carbonate.
- Market Growth: The hyperphosphatemia treatment market is expected to grow, driven by increasing CKD prevalence and supportive reimbursement policies.
- Regional Expansion: Velphoro is expanding its market presence globally, with recent approvals and submissions in various regions.
- Patent Exclusivity: Velphoro is protected by patents until at least 2030, but generic entry could occur sooner if patent challenges are successful.
- Safety and Efficacy: Velphoro has a confirmed safe and effective profile, making it a valuable treatment option for patients with hyperphosphatemia.
FAQs
What is Velphoro used for?
Velphoro is used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
What were the key findings of the PA-CL-CHINA-01 study?
The study demonstrated that Velphoro met its primary efficacy endpoint of non-inferiority versus sevelamer carbonate in lowering and maintaining serum phosphorus levels. It also showed faster decline in serum phosphorus levels and a lower number of tablets taken daily compared to sevelamer carbonate.
When is the generic entry for Velphoro expected?
The earliest date for generic entry is estimated to be July 23, 2030, but this may change due to patent challenges or generic licensing.
What are the main drivers of the hyperphosphatemia treatment market growth?
The main drivers include the increasing prevalence of chronic kidney disease, regulatory approvals, and supportive reimbursement policies.
What is the projected market size for the hyperphosphatemia treatment market by 2029?
The market is expected to reach USD 4.55 billion by 2029, growing at a CAGR of 3.67% from 2024.
Sources
- VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China. Vifor Fresenius Medical Care Renal Pharma, April 30, 2021.
- When do the VELPHORO patents expire, and ... - DrugPatentWatch. DrugPatentWatch.
- Net Present Value Model: Velphoro - GlobalData. GlobalData, November 24, 2022.
- CDR Clinical Review Report for Velphoro - Canada's Drug Agency. Canada's Drug Agency.
- Hyperphosphatemia Treatment Market Size & Share Analysis. Mordor Intelligence.
