Astellas' Evrenzo Gains NICE Reimbursement Approval in UK Following FDA Rejection

Compiled by /newborn

Despite a previous high-profile rejection by the U.S. FDA, FibroGen and its partners have continued to expand the market for the new oral anemia drug Evrenzo (Chinese trade name: 爱瑞卓, generic name: roxadustat) outside the United States.

Recently, Evrenzo has received reimbursement support from the UK's drug cost regulatory body, the National Institute for Health and Care Excellence (NICE).

Evrenzo is a hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor used to treat anemia associated with chronic kidney disease (CKD). Astellas holds the rights to Evrenzo in Europe. Timir Patel, Medical Director of Astellas UK and Ireland, stated in a declaration that the NICE reimbursement coverage decision "is a vote of confidence in Evrenzo as a cost-effective oral treatment option."

NICE's recommendations also come with some restrictions, applying only to patients with stages 3-5 CKD without iron deficiency and those not undergoing dialysis. However, Astellas stated that these restrictions align with Evrenzo's local marketing authorization.

NICE noted in its evaluation that Evrenzo can replace existing injectable erythropoiesis-stimulating agents (ESAs). As commentators for NICE pointed out, "Many anemia patients experience unpleasant feelings and treatment difficulties with injections. Evrenzo, as the world's first oral HIF-PH inhibitor, will become a welcomed oral treatment option."

More importantly, Astellas has provided a confidential discount to make the drug cost-effective for use with NHS resources. Astellas offers Evrenzo in five dosage strengths, with the lowest dose being a 20mg tablet priced at £59.24 (£74.3), and the highest dose being a 150mg tablet priced at £444.32 (£557.27). However, these prices do not reflect the discounts offered by Astellas.

FibroGen and its partners conducted four Evrenzo randomized clinical trials in non-dialysis CKD anemia patients. However, NICE only considered one trial named "Dolomites" because the other trials compared Evrenzo with a placebo.

In the Dolomites trial, data showed that Evrenzo was comparable to Amgen's ESA therapy Aranesp in achieving and maintaining target hemoglobin levels. Moreover, Evrenzo was superior in reducing the need for injectable iron.

The active pharmaceutical ingredient in Evrenzo is roxadustat, discovered by FibroGen and co-developed with Astellas in Japan and the EU, and with AstraZeneca in the United States, China, and other markets. In December 2018, roxadustat (brand name: Aeristral) was first approved in China for the treatment of anemia in adult patients with dialysis-dependent chronic kidney disease (DD-CKD). This marked the first global regulatory approval for roxadustat. In August 2019, the drug received approval in China for a new indication to treat anemia in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Last year, the FDA refused to approve Evrenzo, questioning its side effects, particularly the risk of certain cardiovascular diseases (thrombosis) and death. Currently, AstraZeneca and FibroGen still cannot reach an agreement on whether or how to conduct a new clinical trial.

Meanwhile, European regulators were satisfied with the side effects of Evrenzo. Last August, the European Commission approved Evrenzo for the treatment of anemia associated with CKD in adult patients, including those with NDD-CKD and DD-CKD. Subsequently, Evrenzo also quickly received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Last month, Astellas conducted a pooled analysis of four trials, stating that Evrenzo did not increase the risk of cardiovascular events or death compared to traditional ESAs.

Reference Source:

NICE backs Astellas' Evrenzo in anemia by chronic kidney disease