Astellas anemia drug Evrenzo gets backing from UK NICE after FDA rejection.

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Astellas anemia drug Evrenzo gets backing from UK NICE after FDA rejection.fter FDA rejection

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Astellas anemia drug Evrenzo gets backing from UK NICE after FDA rejection.

Despite previous high-profile rejections by the U.S. FDA, FibroGen and its partners have expanded the market for a new oral anemia drug, Evrenzo (generic name: roxadustat, roxadustat) outside the U.S.

Evrenzo has received reimbursement support from the UK’s drug cost regulator, the National Institute for Health and Clinical Excellence (NICE).

Evrenzo is a hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor indicated for the treatment of anemia associated with chronic kidney disease (CKD). Astellas owns the rights to Evrenzo in Europe.

Astellas UK and Ireland medical director Timir Patel said in a statement that the NICE reimbursement coverage decision “is a vote of confidence in Evrenzo as a cost-effective oral treatment option”.

The NICE recommendation also comes with some limitations and applies only to patients with stage 3-5 CKD without iron deficiency and those not receiving dialysis.

But Astellas said the restrictions were in line with Evrenzo’s local marketing mandate.

In its evaluation, NICE noted that Evrenzo could replace existing injectable erythropoiesis-stimulating agents (ESAs). As a NICE reviewer noted, “Many anemic patients experience unpleasant and difficult treatment with injections. Evrenzo, the world’s first oral HIF-PH inhibitor, will become a popular oral treatment option.”

What’s more, Astellas offered confidential discounts to make the drug cost-effective to use NHS resources. Astellas offers Evrenzo in five dose strengths, with the lowest 20mg tablet priced at 59.24 lbs ($74.3) and the highest 150mg tablet priced at 444.32 lbs ($557.27). Those prices do not reflect the discounts offered by Astellas, however.

Fibrogen and partners conducted four randomized clinical trials of Evrenzo in non-dialysis CKD patients with anemia.

But NICE only considered one trial, called “Dolomites,” because other trials compared Evrenzo to a placebo.

In the Dolomites trial, data showed that Evrenzo was comparable to Amgen’s ESA therapy Aranesp in reaching and maintaining target hemoglobin levels.

Additionally, Evrenzo is superior in reducing the need for injectable iron.

Evrenzo’s active pharmaceutical ingredient is roxadustat, which was discovered by Fibrogate and developed in cooperation with Astellas in Japan, the EU, and with AstraZeneca in the US, China and other markets.

In December 2018, roxadustat (trade name: Arrizo) was the first approved in China for the treatment of anemia in adult patients with dialysis-dependent chronic kidney disease (DD-CKD).

This is also the world’s first regulatory approval for roxadustat. In August 2019, the drug was approved for a new indication in China for the treatment of anemia in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Last year, the FDA refused to approve Evrenzo, raising questions about its side effects, especially some cardiovascular risk (blood clots) and death.

AstraZeneca and Fibrogen are still unable to agree on whether or how to launch a new clinical trial.

Meanwhile, European regulators have expressed satisfaction with Evrenzo’s side effects.

Last August, the European Commission approved Evrenzo for the treatment of CKD-related anemia in adult patients, including patients with NDD-CKD and DD-CKD.

Evrenzo was also quickly approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Last month, Astellas conducted a pooled analysis of four trials, saying Evrenzo did not increase the risk of cardiovascular events or death compared with traditional ESA.

Reference:

NICE backs Astellas’ Evrenzo in anemia by chronic kidney disease

Astellas anemia drug Evrenzo gets backing from UK NICE after FDA rejection.

(source:internet, reference only)

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