FDA Issues Letter to Ardelyx Detailing Deficiencies in Application for Tenapanor

July 21, 2021

While tenapanor has already received approval for treatment of abdominal pain in patients with IBS, the US FDA issued a letter to Ardelyx noting deficiencies in their NDA for an indication related to controlling serum phosphorus in adult patients with CKD on dialysis “preclude discussion” related to labeling and post-marketing requirements.

Dapagliflozin Safe and Effective in Stage 4 Chronic Kidney Disease, DAPA-CKD Analysis Finds

July 20, 2021

A prespecified analysis of patients with stage 4 CKD from DAPA-CKD suggests the magnitude of effects seen with dapagliflozin use among these patients was similar to that seen among patients with normal to moderately impaired kidney function from the trial.

FDA Panel Votes Against Roxadustat, Cites Risk of Thrombotic Events

July 16, 2021

The subject of a July 15 meeting, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 13-1 and 12-2 against recommending approval of roxadustat for treatment of anemia in adult patients with chronic kidney disease not on dialysis and on dialysis, respectively.