Regulatory Affairs

FDA approves updated label of Relypsa’s Veltassa hyperkalemia drug

Published 09 May 2018

The US Food and Drug Administration (FDA) has approved Relypsa’ supplemental new drug application (sNDA) for Veltassa (patiromer) for oral suspension in the treatment of hyperkalemia, or elevated blood potassium levels.

The label update is effective immediately and based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L).  

Relypsa president Scott Garland said: “Since the U.S. approval of Veltassa two years ago, we have seen how the availability of this medicine has been able to significantly transform the way physicians treat hyperkalemia.

 “We are pleased with the FDA's approval of this supplement and believe the updated label will provide patients with greater flexibility in incorporating Veltassa in their daily treatment regimen.”

In the TOURMALINE study, 87.3 percent of the Veltassa with food group and 82.5 percent of the Veltassa without food group achieved potassium levels in the target range at either week 3 or week 4. Patients with higher baseline potassium values generally had greater potassium reductions.

Results were consistent when evaluated by baseline potassium, race, eGFR (an assessment of kidney function) and type 2 diabetes. Rates of adverse events were consistent with previous clinical trials of Veltassa and were similar between study participants who took Veltassa with food (48.2 percent) and those who took it without food (42.1 percent).

The study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive Veltassa once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment.

The primary endpoint was a comparison of the proportion of patients with blood potassium in the target range (3.8 to 5.0 mEq/L) at week 3 or week 4 between the two treatment groups.

The study was conducted at 29 sites in the United States. Of the 112 patients evaluable for efficacy, 65 percent were male, 12.5 percent were African American, 56 percent were Hispanic/Latino, 65 percent were age 65 or older and 62 percent had stage 3b-5 (non-dialysis) chronic kidney disease

documented germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy and were in complete or partial response.

Study 19 is a randomised, double-blinded, placebo-controlled, multi-centre trial designed to assess the efficacy and safety of Lynparza compared against placebo in relapsed, high-grade serous ovarian cancer patients.

The study enrolled 265 patients regardless of BRCA mutation status and who had completed at least two courses of platinum-based chemotherapy and their most recent treatment regimen.

Source: Company Press Release