Positive phase III results achieved for dialysis drug in China
pharmafile | April 30, 2021 | News story | Medical Communications | China, Kideny disease
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro (PA21) in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment.
The study met its primary endpoint, having been designed to demonstrate non-inferiority of the change from baseline at week 12 in serum phosphorus between PA21 and sevelamer carbonate, in order to support market expansion of Velphoro to China.
Dr Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group, said: “We are delighted by the positive results from the PA-CL-CHINA-01 study, which confirm previous data generated in the US and Europe, and reinforce the potential of Velphoro as an important new treatment option for dialysis patients with hyperphosphatemia in China where there is a high prevalence of CKD1.
“This is another important step in our geographic expansion and will further strengthen the position of Velphoro as a global leader in the calcium-free phosphate binder market.”
Velphoro is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with CKD on dialysis. It has so far been launched in over 30 countries, with more than 100,000 patients estimated to use the drug on a yearly basis.
PA-CL-CHINA-01 was an open-label, active-controlled, parallel group, multicentre study with a total of 286 patients randomised, with 142 in the Velphoro arm and 144 in the sevelamer arm.
Patients in the PA-CL-CHINA-01 study who received PA21 experienced additional benefits compared to those in the sevelamer control group, including a faster decline in phosphate levels with a lower number of capsules taken.
Safety results were consistent with the known safety profile of PA21 with no new safety signal observed in Chinese CKD patients with hyperphosphataemia.
Kat Jenkins
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