GSK says anaemia drug shows positive safety profile

By Ludwig Burger

Nov 5 (Reuters) - GlaxoSmithKline said its anaemia
pill for patients with kidney disease was shown to have about
the same side effect risk as the current standard treatment in
two important patient groups, a key advantage in a tight race
with rival drug developers.

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.

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)