FDA accepts sNDA for Veltassa in hyperkalemia.- Relypsa.

Relypsa announced that the FDA has approved a 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 IV 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).

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).

Comment: Hyperkalaemia is an elevated level of potassium in the blood serum which, if left untreated, can lead to palpitations, muscle pain, muscle weakness, numbness and abnormal heart rhythms.