By Ludwig Burger
(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)
