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FRANKFURT, Nov 8 (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 epo, which is the standard treatment for
dialysis patients against lack of red blood cells from kidney
disease.
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 epo, it added.
In a release on Thursday, AstraZeneca already said the drug
was shown to be better than epo - which is short for the hormone
erythropoietin - 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 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.
(Reporting by Ludwig Burger; Editing by Elaine Hardcastle)
