Astellas, FibroGen: Positive Euro panel opinion in chronic kidney disease

 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).1 CKD impacts one in 10 people globally, of whom one in five are affected by anemia.2, 3 Anemia of CKD is associated with significant impairment in quality of life and progression to adverse cardiovascular (CV) and renal outcomes.4-6 Anemia of CKD is often untreated or not treated to target.4-6

If approved by the European Commission (EC), roxadustat will be the first orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) available in Europe. Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to erythropoiesis-stimulating agents (ESAs). As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia with a reduced need for intravenous iron.

https://finance.yahoo.com/news/astellas-receives-positive-chmp-opinion-131500087.html