European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Roxadustat
FibroGen, Inc (FGEN)
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Source: GlobeNewswire
TOKYO and SAN FRANCISCO, May 21, 2020 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”) today announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review. The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.1-7 The MAA dossier includes the DOLOMITES study, the results of which will be disclosed later this year.8,9 Results from these studies support roxadustat as efficacious in increasing and maintaining target hemoglobin levels with reduced use of intravenous iron in adult patients with CKD anemia, both those who are dialysis dependent (DD) and those non-dialysis dependent (NDD). These data also support a favorable risk:b
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FGEN
Earnings
- 2/26/24 - Miss
FGEN
Sec Filings
- 4/24/24 - Form DEFA14A
- 4/24/24 - Form DEF
- 4/24/24 - Form 3
- FGEN's page on the SEC website