BRIEF—Astellas files sNDA for Evrenzo in Japan

Japanese drug major Astellas Pharma and USA-based FibroGen today announced the submission of a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labor and Welfare to gain marketing approval for Evrenzo (roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients.

Roxadustat was approved in Japan for the treatment of anemia associated with CKD in dialysis dependent (DD) patients in September 2019 and launched for use in this indication in November 2019.

FibroGen granted certain geographical rights to Evrenzo to Astellas in 2005, under a deal that in total could earn it up to $2 billion.

The sNDA for the use of roxadustat in NDD-CKD patients is supported by three studies in more than 500 Japanese patients, which establish the profile within this group of patients.

The first, an open-label Phase III conversion study versus active comparator, darbepoetin alfa (genetical recombination) (“darbepoetin alfa”), met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.

Roxadustat was well tolerated and the safety profile of roxadustat was comparable to that of darbepoetin alfa.

The other two studies (one Phase III and one Phase II) supports the safety and efficacy in patients naïve to erythropoiesis-stimulating agents (ESAs).