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

Roxadustat Stacks Up To Darbepoietin In Non-Dialysis Anemia

Plus Positive CV Signals

Executive Summary

Astellas’s oral HIF-PH inhibitor shows non-inferiority to one established ESA in head-to-head trial and while there were cardiovascular benefits, the picture is complex.

You may also be interested in...



East Shines Over West? US Rejection Puts Roxadustat's China Approval In New Spotlight

Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording. 

US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count

The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.

Akebia's Vadadustat Misses In Non-Dialysis CKD, But Filings Still Planned For 2021

HIF-PHI inhibitor failed to show non-inferiority to ESAs in the primary cardiovascular safety endpoint of a Phase III program for the treatment of anemia due to chronic kidney disease.

Topics

Related Companies

UsernamePublicRestriction

Register

SC142367

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel