Regulatory U.S. FDA reject anemia drug Evrenzo approved by UK’s...

U.S. FDA reject anemia drug Evrenzo approved by UK’s NICE 


Fibrogen and Astellas’ anemia medicine; Evrenzo, had been rejected by the U.S. Food and Drug Administration (FDA) previously. However, the partners have been able to secure approval for their developed anemia drug in the European market. 

The EU-approved anemia drug Evrenzo is also known as roxadustat. The therapy has been able to secure reimbursement backing from England-based regulatory agency NICE.

The National Institute for Health and Care Excellence (NICE) endorsement through their coverage decision has been taken as confidence in Evrenzo’s capabilities as a reasonably priced therapy option for anemic patients suffering from chronic kidney disease. 

The drug is only recommended by NICE for patients in the 3rd to 5th stage of chronic kidney disease, in patients not on dialysis. NICE found that Evrenzo can serve as an alternative to erythropoiesis-stimulating agents (ESAs) as they are injectables while Evrenzo is an oral tablet. The oral therapy is the first of its kind (HIF-PH inhibitor) to be approved. 

Furthermore, the drug has been made cost-effective through a special discount in order to be a good use of NHS’ limited resources. The drug is available in 20-mg and 150-mg packings 12 packs for $74 and $557 respectively, without a discount. 

While NICE only took one clinical trial into consideration, Evrenzo was tested by FibroGen in randomized clinical trials. The trials included patients suffering from chronic kidney disease who were not on dialysis. 

In the trial analyzed by NICE, which is known as Dolomites, the anemia medicine showed that it was comparable to another therapy in the same category, i.e Amgen’s Aranesp. Evrenzo was able to both attain and maintain the hemoglobin levels Aranesp is successfully able to achieve. Evrenzo was also more effective at reducing the requirement of infusions of iron.

NICE did not consider the other 3 trials as they included a comparison with a placebo. 

Evrenzo was able to seize its first approval in 2018 in China, through a  FibroGen and AstraZeneca partnership. However, the FDA did not follow suit and rejected the drug based on its side effects. The FDA cited drug-associated side effects of blood clots, cardiovascular complications and death as a basis for the medicine’s rejection. An agreement by the partners has not been reached on if and when a new clinical trial should be conducted to reapply for approval from the FDA.

European regulatory agencies have given the green light to the anemia drug with safety clearance given to the side effects associated with the medicine. The European Commission has allowed for Evrenzo to be used in symptomatic patients of anemia with chronic kidney disease. 

The U.K. Medicines and Healthcare Regulatory Agency quickly cleared the drug after the Commission’s approval. Thus, the anemia treatment is available in the European region but not in the U.S. 

Astellas had revealed the pooled analysis of four trials testing the Evrenzo’s side effects in May. The trial results had found that the drug did not exacerbate the occurrence of cardiovascular episodes or lead to any more fatality than another ESA.

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