FibroGen, Inc. FGEN along with partner Astellas Pharma Inc. announced that it has received a marketing approval for Evrenzo (roxadustat) in Japan. The Japanese regulatory authority has given a nod to roxadustat for the treatment of anemia caused by chronic kidney disease (CKD) in dialysis-dependent patients.
The approval was granted based on data from the four phase III studies, which evaluated roxadustat in the above-mentioned patient population. In the study, roxadustat was well tolerated and was effective at raising the hemoglobin levels in CKD anemia patients who are on dialysis.
Notably, this is the first approval for roxadustat under the FibroGen and Astellas collaboration to address this debilitating condition for patients in Japan. Apart from Japan, both companies are jointly developing the drug in Europe, the Middle East and South Africa.
Shares of FibroGen have lost 14.3% so far this year against the industry’s increase of 6.3%.
We remind investors that roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor, is being jointly developed by FibroGen and AstraZeneca AZN for treating anemia in CKD patients in the United States and China. A regulatory application looking for approval of roxadustat in the United States is expected to be filed in the second half of 2019.
Moreover, roxadustat is being evaluated in a phase III study for treating anemia associated with myelodysplastic syndromes (MDS) in the United States and Europe.
Last December, the Chinese regulatory agency approved roxadustat for treating anemia in CKD patients who are on dialysis.
Meanwhile, last month, FibroGen China, a wholly-owned subsidiary of FibroGen, received a second marketing approval for roxadustat in China. This time, the Chinese regulatory authority approved the drug for the treatment of anemia caused by CKD in non-dialysis-dependent patients.
Roxadustat is also being investigated in a phase II/III study for treating anemia associated with MDS in China.
Following this label expansion nod, China became the first country to approve roxadustat for all CKD patients, who experience anemia whether on dialysis or not. Both AstraZeneca and FibroGen China plan to launch roxadustat later this year.
Zacks Rank & Other Key Picks
FibroGen currently sports a Zacks Rank #1 (Strong Buy). Other stocks worth considering in the same sector include Verrica Pharmaceuticals Inc. VRCA and Spectrum Pharmaceuticals, Inc. SPPI, both flaunting the same solid Zacks Rank as FibroGen.You can see the complete list of today’s Zacks #1 Rank stocks here.
Verrica Pharmaceuticals’ loss per share estimates have been narrowed 4.4% for 2019 and 0.5% for 2020 over the past 60 days. The stock has skyrocketed 71.8% year to date.
Spectrum Pharmaceuticals’ loss per share estimates have been narrowed 19.8% for 2019 and 19.8% for 2020 over the past 60 days. The stock has gained 8% year to date.
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