Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FibroGen, Inc.

http://www.fibrogen.com

Latest From FibroGen, Inc.

Roxadustat Rejection Has Lessons For Other Sponsors

A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.

Advisory Committees Clinical Trials

GSK Looks To Capitalize On AstraZeneca’s Anemia Drug Knock-Back

AstraZeneca and FibroGen hit another safety roadblock with roxadustat, while GSK is hoping it might catch up with its rivals in the US.

Commercial Companies

FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy

But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.

Advisory Committees Drug Review

FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin

Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.

Advisory Committees Drug Review
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Medical Devices
    • Biomaterials
  • Other Names / Subsidiaries
    • FibroGen China Anemia Holdings Ltd.
    • FibroGen (China) Medical Technology Development Co., Ltd.
    • FibroGen Europe Oy
    • FibroGen International (Cayman) Limited
    • FibroGen International (Hong Kong) Limited
    • Skin Sciences, Inc.
UsernamePublicRestriction

Register