This article is more than 5 years old. Information may no longer be current.
FDA approves agent for treatment of hyperkalemia
Click Here to Manage Email Alerts
The FDA and Relypsa announced that the agency has approved patiromer, a potassium-binding agent, for the treatment of patients with hyperkalemia.
Patiromer (Veltassa, Relypsa) is the first new medication approved by the FDA to treat hyperkalemia in more than 50 years, according to a press release from Relypsa.
Hyperkalemia is common in patients with HF and/or chronic kidney disease, and can put them at elevated risk for arrhythmia disorders and sudden cardiac death, especially if they are taking renin-angiotensin-aldosterone system inhibitors, according to releases from the company and the agency.
“Too much potassium in the blood can lead to dangerous, even fatal changes in heart rhythm,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, said in a press release from the agency. “It is important to have treatment options for hyperkalemia available to patients.”
According to the company release, FDA approval was based in part on results from the phase 3 OPAL-HK study, in which patients with CKD and hyperkalemia taking RAAS inhibitors had decreased potassium levels when taking patiromer (mean decrease, –1.01 ±0.03 mEq/L; P < .001). Among those taking patiromer, 76% had potassium levels within the target range (3.8 mEq/L to < 5.1 mEq/L) at 4 weeks. In a subsequent portion of the trial, those assigned patiromer had no change in potassium from baseline, but patients assigned placebo had increased potassium levels (0.72 mEq/L; P < .001).
The drug is expected to be available in January 2016, according to the company release.
Disclosure: Stockbridge is director of the division of cardiovascular and renal products at the FDA.
Perspective
Back to Top
Javed Butler, MD, MPH
There are two levels of potential benefit from this approval. One is that for people who run into problems with hyperkalemia, we now have a safer therapeutic option. However, the bigger interest is not necessarily with episodic hyperkalemia, but with whether you can use this safer long-term therapy to prevent development of hyperkalemia in patients with HF, and be able to give them optimal doses of RAAS inhibitors such as ACE inhibitors or mineralocorticoid receptor antagonists and hopefully improve their outcomes. We need some prospective data from newer trials for this approach, and the approval opens the door to start doing trials and administering therapies to patients who have traditionally been excluded from trials or therapies once they have an episode of hyperkalemia.
Click Here to Manage Email Alerts