28 June 2021 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency 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, Japanese pharmaceutical company Astellas Pharma Inc. (TSX: 4503) and FibroGen, Inc. (NASDAQ: FGEN) said.

CKD impacts one in 10 people globally, of whom one in five are affected by anemia.

Anemia of CKD is associated with significant impairment in quality of life and progression to adverse cardiovascular and renal outcomes.

Anemia of CKD is often untreated or not treated to target.

If approved by the European Commission, roxadustat will be the first orally administered inhibitor of hypoxia-inducible factor prolyl hydroxylase available in Europe.

Roxadustat increases hemoglobin levels through a different mechanism of action compared to erythropoiesis-stimulating agents.

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.

The positive CHMP opinion is based on the results from a comprehensive pivotal Phase 3 program comprising of eight multicenter and randomized studies, which involved 9,600 patients worldwide.

The results of this program support roxadustat as efficacious in achieving and maintaining target Hb levels (10-12g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior ESA treatment.

The safety profile observed in the roxadustat development program is reflective of the CKD populations studied and comparable to ESAs.

The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.

The EC has 67 days from the CHMP opinion to issue a final decision.

Chronic kidney disease is a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end-stage renal disease, requiring dialysis or kidney transplant.

Many patients with CKD die of cardiovascular complications before progressing to kidney failure and as such the prevalence of early kidney disease is much greater than end-stage disease.

CKD impacts one in 10 people globally and is predicted to become the fifth most common cause of premature death globally by 2040.

Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD affecting approximately 20% of CKD patients.

Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life.

Blood transfusions are used for treating severe anemia, however, they may reduce a patient's opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors, that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin.

Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes and Phase 2 for chemotherapy-induced anemia.

Roxadustat is approved in Japan, China and Chile for the treatment of anemia of CKD in adult patients on dialysis and not on dialysis. In the US, the New Drug Application is under review by the US Food and Drug Administration.

Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe and are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa.

FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in the US, China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality.

Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners.

Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

FibroGen is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics.

The company applies its pioneering expertise in hypoxia-inducible factor and connective tissue growth factor biology to advance innovative medicines for the treatment of unmet needs.

The company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease.

Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes and for chemotherapy-induced anemia.

Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis.