Diabetes, hypertension and heart disease are the most common causes of chronic kidney diseases (CKD) in developed and developing countries. The prevalence of kidney disease is increasing dramatically and the cost of treating this growing epidemic represents an enormous burden on healthcare systems worldwide. Between 8 and 10% of the adult population have some form of kidney damage, and every year millions die prematurely of complications related to CKD.
As there is no treatment for CKD apart from dialysis and transplantation, prevention and early detection to delay severe kidney failure are key to maintaining kidney function. Medicines have been approved on the recommendation of the Agency's Committee for Medicinal Products for Human Use (CHMP) to both prevent and treat diseases causing CKD, and to treat conditions caused by CKD such as anaemia and hyperphosphataemia. In the European Union (EU), all new medicines for diabetes are authorised via the Agency, rather than in each Member State individually.
The Agency is currently drafting a guideline on the clinical investigation of medicines to slow the progression of renal insufficiency, which will be the first EU guideline in this area. The Agency expects to release this guideline for public consultation during the second quarter of this year.