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 GSK said on Friday that risk measures to determine whether its drug
did not pose a higher risk than versions of the current treatment
known as Epo, came in better than the predefined hurdle in two
trials treating patients on dialysis and those not yet on dialysis.
In the trials, its drug daprodustat also improved or maintained
haemoglobin levels, when compared to the standard of care, the
company added.
Analysts have said that safety from side effects such as heart
attack or stroke will be a crucial factor to differentiate
daprodustat, which GSK has said could have annual sales of as much
as 1 billion pounds ($1.35 billion), from competing pills under
development by AstraZeneca and others.
Anaemia is characterized by a low count of red blood cells or lack
of the oxygen-carrying protein haemoglobin in those cells. Patients
with kidney disease - ever growing in number due to a rise in
obesity, diabetes and high blood pressure - suffer increasingly from
anaemia as renal function declines.
In later disease stages, particularly when depending on
blood-cleansing dialysis, patients currently receive injections of a
synthetic version of hormone erythropoietin, or Epo, to stimulate
red-blood cell production. But the treatment raises the risk of
dangerous heart attacks and strokes.
The new class of more convenient oral drugs, known as HIF-PH
inhibitors, has attracted several competing drugmakers.
[to top of second column] |
 AstraZeneca and Fibrogen in
August suffered a major setback with their drug
roxadustat, part of the same HIF-PH category,
when the U.S. Food and Drug Administration (FDA)
in August declined approval, citing the need for
an additional clinical study on safety.
Another HIF-PH inhibitor, vadadustat by Akebia
and its Japanese partner Otsuka Pharmaceutical,
has been under review by the U.S. FDA since
June.
GSK's daprodustat is only cleared for use in
Japan and GSK said it would make requests for
approval with other regulators worldwide,
underpinned by the new data. The company had
published a short summary of the positive
results in June.
The positive results come as a boost for GSK
boss Emma Walmsley, whose strategy to separately
list its consumer health unit has been
criticized by activist investor Elliott.
Daprodustat is one of a group of GSK drug
candidates in late stages of development where
the company sees potential for annual peak sales
of more than 20 billion pounds.
($1 = 0.7428 pounds)
(Reporting by Yadarisa Shabong, Sachin Ravikumar
and Pushkala Aripaka in Bengaluru; Editing by
Rashmi Aich, Louise Heavens, Elaine Hardcastle)
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