Amgen’s Aranesp gets FDA approval

Amgen has announced that the US Food and Drug Administration (FDA) has given its approval to an every-three-week dosing to treat chemotherapy-induced anaemia with Aranesp.

It is the only FDA-approved erythropoiesis-stimulating agent that qualifies for every-three-week administration.

The approval means that the Aranesp label, in addition to the recommended starting dose of 2.25 mcg/kg once weekly, also recommends 500 mcg once every three weeks.

Willard Dere, chief medical officer and senior vice president of global development at Amgen, said: “Amgen developed Aranesp to provide cancer patients with a long-acting and effective means to treat chemotherapy-induced anaemia, a common side effect of chemotherapy.

“The approval of an extended dosing protocol for Aranesp is an important milestone allowing anaemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens.”

The announcement will allow anaemia sufferers, who have to cope with fatigue, breathing difficulties and dizziness, to visit a clinic less often for treatment.

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