Safety Data on AstraZeneca Anaemia Drug Points to Potential Use in Dialysis

By Reuters Staff

November 08, 2019

FRANKFURT (Reuters) - AstraZeneca said that safety data on roxadustat underpinned the British drugmaker's hopes for the anaemia drug to become a standard treatment for patients with kidney disease.

It said pooled data from several late-stage trials showed that roxadustat did not increase the risk of potentially deadly cardiovascular complications like heart attacks and strokes when used instead of epoetin alfa, a current medicine used to treat anaemia.

For a subgroup of patients that had just recently gone on dialysis the cardiovascular risk was about one third lower for patients on roxadustat compared with those on epoetin alfa, it added.

In a release on Thursday, AstraZeneca already said the drug was shown to be better than epoetin alfa at improving the red blood cell count in patients on dialysis.

AstraZeneca hopes that roxadustat will in future be cleared for use to fight anaemia in kidney disease patients that do not yet require blood cleansing via dialysis.

This group is currently not given epo because of the cardiovascular risks associated with the hormone.

Trial data showed that giving roxadustat against anaemia did not increase cardiovascular risk, Astra said.

Astra executive Mene Pangalos said the results "reinforce our confidence in the potential of roxadustat to address significant unmet medical needs among patients with anaemia from chronic kidney disease, particularly for those who have recently started dialysis".

The results were presented in an oral late-breaking abstract session at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington, D.C.

The drug, for which AstraZeneca already secured initial Chinese market approval last year, is expected to reach annual revenue of $870 million by 2024, according to Refinitiv data on analyst estimates.

Deutsche Bank analysts said this month a favourable safety profile could propel the drug to blockbuster sales, an industry term for the $1 billion mark in annual revenues. AstraZeneca would not disclose sales projections.

The company said it would file for U.S. regulatory approval this year.

Certain regional rights on the drug are held by FibroGen and Astellas Pharma.