Roxadustat (Evrenzo™), Targeting Nobel Prize-Winning Hypoxia Pathway, Approved by European Commission for Anemia in Chronic Kidney Disease
Astellas
Pharmaceutical R&D Manufacturer
FibroGen
Developer of Oral Small Molecule Inhibitors
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Astellas Pharma and FibroGen announced today that the European Commission (EC) has granted marketing authorization for Evrenzo (roxadustat) for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients.
The global prevalence of CKD is 1 in 10, with 1 in 5 patients affected by anemia. CKD-associated anemia is associated with reduced quality of life and progression to adverse cardiovascular and renal outcomes.
Roxadustat is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the European Union. Compared with erythropoiesis-stimulating agents (ESAs), which are typically administered in combination with iron supplements, it increases hemoglobin (Hb) levels through a different mechanism of action. As a HIF-PHI, roxadustat activates the body's natural response to decreased oxygen levels in the blood. This response involves the regulation of multiple coordinated processes, enabling the management of anemia with a reduced need for intravenous iron supplementation. Notably, the drug's target, the "oxygen-sensing pathway," was awarded the Nobel Prize in 2019.
This approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on results from a pivotal Phase 3 development program comprising eight multicenter, randomized studies. The program involved 9,600 patients worldwide. The results demonstrated that, regardless of dialysis status or prior ESA treatment, roxadustat effectively achieved and maintained target hemoglobin (Hb) levels (10–12 g/dL) in patients with symptomatic anemia associated with chronic kidney disease (CKD). The safety profile observed in the roxadustat development program was comparable to that of ESAs, reflecting the clinical characteristics of the CKD patients studied.
References:
[1] Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease. Retrieved 2021-08-20, from https://www.prnewswire.com/news-releases/astellas-receives-european-commission-approval-for-first-in-class-evrenzo-roxadustat-for-adult-patients-with-symptomatic-anemia-of-chronic-kidney-disease-301359297.html
(Original text abridged)
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