Recently, FibroGen announced that it has received a complete response letter from the US FDA regarding the new drug application (NDA) for roxadustat for the treatment of chronic renal (CKD) anemia. The letter stated that the FDA will currently not approve the NDA application for roxastat and requires FibroGen to conduct additional clinical studies on roxastat before resubmitting the marketing application.

Enrique Conterno, CEO of FibroGen, said: "We are deeply disappointed by this result. It is an unfortunate day for patients with CKD anemia in the United States." "Roxadustat is changing the lives of patients around the world. We and ours Partner AstraZeneca will discuss the next steps of the product in the United States."

Roxastat is an oral firsit-in-class small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, which can increase the production of endogenous erythropoietin and improve iron absorption And mobilize and down-regulate hepcidin to promote erythropoiesis. This achievement has been awarded the 2019 Nobel Prize in Physiology or Medicine. Roxastat may change the treatment of CKD anemia.

On July 15, the U.S. FDA Cardiovascular and Renal Drug Advisory Committee (CRDAC) voted against the approval of rosarestat for the treatment of patients with chronic kidney disease anemia. The voting result for patients with CKD anemia on dialysis was 12:2. , The voting result for non-dialysis CKD anemia patients was 13:1. The committee's vote is based on data from a global phase III clinical project involving more than 8,000 patients.

For rosarestat, the FDA's initial PDUFA deadline was December 2020, but the agency later extended its review to March 2021. In March of this year, the FDA stated that it would request an advisory committee meeting, which further postponed the process.

After experiencing successive delays, the partners encountered another setback in April. FibroGen admitted that in order to make the data more beneficial, they changed the standards used to analyze rosastat heart safety data.

Industry observers initially thought the drug was a blockbuster because they believed it could take market share from the standard therapy recombinant human erythropoietin and also gain additional market share from non-dialysis patients.

Roxastat has been approved in China, Japan, Chile and South Korea for the treatment of chronic renal anemia in non-dialysis dependent (NDD) and dialysis dependent (DD) adults. And it has received positive opinions from the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP).

Astellas and FibroGen are jointly responsible for the development and commercialization of Roxastat in Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East and South Africa. AstraZeneca and FibroGen are jointly responsible for development and commercialization in the United States, China, other markets in the Americas, Australia/New Zealand and Southeast Asia.