GSK Says Anemia Drug Has Positive Safety Profile, Health News, ET HealthWorld

By Ludwig Burger

GlaxoSmithKline said its anemia pill for patients with kidney failure had about the same risk of side effects as current standard therapy in two large patient groups, a key benefit in a tight race with rival drug developers.

GSK said on Friday that the risk measurements for determining whether its drug was at a higher risk than versions of the current treatment known as Epo, were better than the pre-defined hurdle in two trials treating patients on dialysis. and those not yet on dialysis.

In trials, its drug daprodustat also improved or maintained hemoglobin levels, compared to standard of care, the company added.

Analysts said safety against side effects such as heart attacks or strokes will be a crucial factor in differentiating daprodustat, which GSK believes could generate annual sales of up to £ 1 billion (1.35 billion dollars), competing pills in development by AstraZeneca. and others.

Anemia is characterized by a low number of red blood cells or a lack of hemoglobin, an oxygen-carrying protein in these cells. Patients with kidney failure – more and more due to increased obesity, diabetes and high blood pressure – experience more and more anemia as kidney function declines.

In later stages of the disease, especially when dependent on dialysis to purify the blood, patients are currently injected with a synthetic version of the hormone erythropoietin, or Epo, to stimulate the production of red blood cells. But treatment increases the risk of dangerous heart attacks and strokes.

The new, more convenient oral drug class known as HIF-PH inhibitors has attracted several competing drug manufacturers.

AstraZeneca and Fibrogen suffered a major setback in August with their drug roxadustat, which is in the same HIF-PH category, when the US Food and Drug Administration (FDA) denied approval in August citing the need. additional clinical safety study.

Another HIF-PH inhibitor, vadadustat from Akebia and its Japanese partner Otsuka Pharmaceutical, has been under review by the US FDA since June.

GSK’s daprodustat is only licensed in Japan, and GSK has said it will apply for approval from other regulators around the world, supported by the new data. The company had released a brief summary of the positive results in June.

The positive results are a boost for GSK boss Emma Walmsley, whose strategy of separately listing her consumer health unit has been criticized by activist investor Elliott. Daprodustat is one of a group of GSK drug candidates at advanced stages of development where the company sees potential for maximum annual sales of over £ 20 billion. ($ 1 = 0.7428 pounds)

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