FDA Committee of Experts Opposes Approval of Roxastat

Text | pick up shells

On July 15, the US FDA Cardiovascular and Renal Drug Advisory Committee (CRDAC) voted against the approval of the oral HIF-PH inhibitor Roxadustat (Roxadustat) developed by Fabojin/AstraZeneca for the treatment of patients with chronic kidney disease and anemia.

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

The expert committee opposed the approval of roxastat for the treatment of chronic kidney disease anemia in non-dialysis patients, mainly because of concerns about the overall situation of the safety data, and they expressed their concern about the post-marketing study proposed by the partner (AstraZeneca) to understand more Many proposals regarding the drug's cardiac safety are doubtful

The only person who voted for it was Dr.

For CKD patients on dialysis, the expert committee voted against approval with a vote of 2:12

During the meeting, the panel members of the FDA Cardiovascular and Renal Medicine Advisory Committee discussed the safety and effectiveness of the drug in dialysis and non-dialysis patients, as well as the registration criteria for clinical research projects, and a potential post-marketing study

Most of the discussion focused on the safety of use by medical institutions and the application materials submitted by the company

At a public hearing before the vote, patients and doctors asked experts to support the drug's listing, citing the challenges of current treatments and the advantages of oral drugs

New York City nephrologist Dr.

The result of the vote of the FDA Expert Advisory Committee has greatly increased the risk of uncertainty in FDA's approval of the drug

For rosarestat, the FDA's initial PDUFA deadline was December 2020, but the agency later extended its review to March 2021

After experiencing successive delays, the partners encountered another setback in April.

The industry view personnel initially considered the drug to be a blockbuster because they believed that it could seize 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

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