Velphoro sucroferric oxyhydroxide regulatory update

EMA’s CHMP issued a positive opinion recommending approval of Velphoro sucroferric oxyhydroxide from Galenica’s Vifor Pharma Ltd. specialty pharma business to control serum phosphorus levels in adult patients with chronic kidney disease (CKD) on hemodialysis or peritoneal dialysis. Vifor expects a final decision from the European Commission in the fall. Partner Fresenius’ Fresenius Medical Care North America unit markets the oral iron-based phosphate binder in the U.S., where it is approved to control serum phosphorus levels in CKD patients on dialysis. ...