US-based biopharmaceutical firm FibroGen and its division FibroGen China Medical Technology Development has reported positive topline results from the two Phase III clinical trials of roxadustat to treat anaemia in China.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Roxadustat is an orally administered small molecule developed for the treatment of anaemia in dialysis-dependent CKD (DD-CKD) and non-dialysis-dependent CKD (NDD-CKD) patients.

The drug is claimed to be a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which improves endogenous erythropoietin and iron regulation, as well as minimises hepcidin, resulting in increased erythropoiesis.

The double-blind, placebo-controlled NDD-CKD trial conducted in 151 anaemia patients indicated that roxadustat met the primary endpoint by statistically enhancing hemoglobin (Hb) levels, when compared to placebo over eight weeks.

See Also:

The drug is also reported to have met the secondary end point of Hb response.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
"The results indicated that adverse events were consistent with previous clinical trials of roxadustat in the CKD patients without any new or unexpected safety signals detected."

The second dialysis study in 304 patients randomised to and treated with roxadustat or epoetin alfa, showed Hb change from baseline to the Hb level averaged during the last five weeks of the 26-week treatment period.

The results indicated that adverse events were consistent with previous clinical trials of roxadustat in the CKD patients without any new or unexpected safety signals detected.

FibroGen has partnered with AstraZeneca to develop and commercialise roxadustat in markets such as China and the US, while the firm collaborated with Astellas for Europe, Japan, the Commonwealth of Independent States, the Middle East and Africa.

A roxadustat myelodysplastic syndrome (MDS) Phase II/III clinical trial application (CTA) is currently under review by the China Food and Drug Administration (CFDA), as well as a Phase III trial is being initiated in the US to treat anaemia patients with MDS.

Image: The hand of a person with severe anaemia compared to one without. Photo: courtesy of James Heilman / Wikipedia.