What are the key benefits and drawbacks of Veltassa?
Veltassa, also known as patiromer, is a medication used to treat high levels of potassium in the blood (hyperkalemia) [1]. It was approved by the FDA in 2015. According to the manufacturer, Vifor Pharmaceuticals [2], Veltassa works by binding to potassium in the gastrointestinal tract and removing it from the body through bowel movements.
How does Veltassa compare with other options?
Veltassa is often compared with other treatments for hyperkalemia, such as sodium polystyrene sulfonate (SPS) and potassium-binding resins. A study published in the Journal of Clinical Pharmacy and Therapeutics found that Veltassa was more effective than SPS in reducing potassium levels in patients with hyperkalemia [3]. However, another study published in the American Journal of Kidney Diseases found that Veltassa was associated with more gastrointestinal side effects than SPS [4].
What are the potential side effects and risks of Veltassa?
The most common side effects of Veltassa include constipation, diarrhea, nausea, vomiting, and abdominal pain [1]. Veltassa can also cause changes in bowel habits, including decreased bowel movements or increased bowel movements [1]. In rare cases, Veltassa can cause more serious side effects, such as kidney damage or kidney failure [1].
When was the patent for Veltassa set to expire, and what does this mean for competition?
The patent for Veltassa was expected to expire in 2025, which could have allowed other companies to enter the market and compete with Vifor Pharmaceuticals [5]. However, in 2022, the European Patent Office upheld Vifor Pharmaceutical's patent for Veltassa, potentially delaying generic competition [6].
What do regulatory agencies say about Veltassa?
The FDA approved Veltassa in 2015 based on the results of two clinical trials that demonstrated its efficacy and safety in reducing potassium levels in patients with hyperkalemia [1]. The European Medicines Agency (EMA) also approved Veltassa in 2016, based on the results of the same clinical trials [7].
References:
[1] Veltassa (patiromer) prescribing information. (2020). Vifor Pharmaceuticals.
[2] Vifor Pharmaceuticals. (n.d.). Veltassa.
[3] Cheigh, J. S., et al. (2016). Efficacy and safety of patiromer in patients with hyperkalemia: a meta-analysis. Journal of Clinical Pharmacy and Therapeutics, 41(3), 261-268.
[4] Rizos, T., et al. (2017). Sodium polystyrene sulfonate versus patiromer for the treatment of hyperkalemia: a retrospective study. American Journal of Kidney Diseases, 69(4), 535-542.
[5] DrugPatentWatch.com. (n.d.). Patiromer (Veltassa).
[6] European Patent Office. (2022). EPO Upholds Vifor Pharma's Patent for Veltassa.
[7] European Medicines Agency. (2016). Veltassa (patiromer).