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FibroGen's (FGEN) Evrenzo Approved in Japan for Another Indication

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FibroGen, Inc. (FGEN - Free Report) , along with partner Astellas Pharma Inc. announced that it has received a second marketing approval for Evrenzo (roxadustat) in Japan. The Japanese regulatory authority has now given a nod to roxadustat for the treatment of anemia of chronic kidney disease (“CKD”) in adult patients who are not on dialysis.

Notably, roxadustat was approved for the treatment of anemia caused by CKD in dialysis-dependent patients in September 2019.

Following the second approval, roxadustat can now be given to patients with anemia of CKD regardless of being on dialysis or not in Japan. This should broaden the drug’s eligible patient population in the days ahead. FibroGen will receive $15 million as milestone payment from Astellas after roxadustat’s label was expanded by the Japanese regulatory body.

This label expansion nod was based on data from three clinical studies which evaluated roxadustat in more than 500 patients with anemia of CKD who are not on dialysis in Japan. In the first study, roxadustat met the primary efficacy endpoint of non-inferiority and maintained hemoglobin (Hb) levels over time as compared to Amgen’s (AMGN - Free Report) Aranesp (darbepoetin alfa). The other studies supported the safety and efficacy of roxadustat in erythropoiesis-stimulating agent untreated patients.

We note that apart from Japan, FibroGen and Astellas are jointly developing roxadustat in Europe, the Middle East, Russia, Turkey and South Africa. The drug is currently under review in EU for treatment of anemia of CKD in both dialysis as well as non-dialysis patients.

Shares of FibroGen have lost 6.4% so far this year compared to the industry’s decrease of 2.3%.

price chart for FGEN


We remind investors that roxadustat is being jointly developed by FibroGen and AstraZeneca (AZN - Free Report) for treating anemia in CKD patients in the United States.

In February 2020, the FDA accepted the new drug application for roxadustat for the treatment of anemia of CKD in both non-dialysis-dependent and dialysis-dependent patients. The regulatory body has set an action date of Dec 20, 2020.

Meanwhile, roxadustat is also being evaluated in a phase III study for treating anemia associated with myelodysplastic syndromes and phase II study for the treatment of chemotherapy-induced anemia.

Zacks Rank & Key Pick

FibroGen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ironwood’s earnings estimates have been revised 33.3% and 88.5% upward for 2020 and 2021 each over the past 60 days.

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