FDA accepts supplemental new drug application to use Veltassa with or without food

The FDA has approved a supplemental new drug application for Veltassa for oral suspension in the treatment of hyperkalemia. The label update is effective immediately, company officials said, and the updated label may allow for increased dosing flexibility for patients with hyperkalemia.

“Since the U.S. approval of Veltassa [patiromer, Relypsa Inc.] 2 years ago, we have seen how the availability of this medicine has been able to significantly transform the way physicians treat hyperkalemia,” Scott Garland, president of Relypsa, said in a company press release. “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.”

The approval is 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 of 3.8 mEq/L to 5 mEq/L. In the study, 87.3% of participants who took Veltassa with food and 82.5% of participants who took Veltassa without food achieved potassium levels in the target range at either week 3 or week 4. Patients with higher baseline potassium values had greater potassium reductions. Results were consistent by baseline potassium, race, estimated glomerular filtration rate and type 2 diabetes. Rates of adverse events were consistent with previous clinical trials of Veltassa and were similar between patients who took Veltassa with food and those who took it without food.

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