Amgen’s Aranesp blood cell disorder drug meets primary endpoint in phase 3 study

The drug also improved erythroid response, an important measure of the formation of new red blood cells.

The company said data from the phase 3 Arcade study was consistent with the known safety profile of Aranesp and the adverse effects were generally balanced between the patients who were treated with the drug in the trial and those given a placebo.

However, adverse events like fatigue, pyrexia, headache and myalgia were about 5% more frequent than the placebo group.

Aranesp was evaluated in 146 patients with low or intermediate-1 risk MDS who had not earlier taken erythropoiesis-stimulating agents or biologic response modifiers.

Amgen executive vice president of research and development Sean Harper said: "We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients."

Aranesp is indicated to treat anemia caused by chronic kidney disease in patients on dialysis and not on dialysis.

It is also used to treat anemia caused by chemotherapy that will be used for at least two months after scommencing Aranesp.

MDS occurs when immature blood cells do not mature in the bone marrow. It affects over 30,000 people in the US per year.

Image: Aranesp reduced the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS. Photo: courtesy of dream designs/FreeDigitalPhotos.net.