Amgen blood cell disorder drug meets primary goal in phase 3 trial

Feb 15 (Reuters) - Biopharmaceutical company Amgen Inc said on Monday its Aranesp drug met its primary goal of reducing the incidence of red blood cell transfusions in anemic patients suffering from Myelodysplastic Syndromes (MDS) in a phase 3 trial.

MDS, which is among the most common type of bone marrow failure syndromes in adults, occurs when blood cells do not mature in the bone marrow, putting patients at risk of infection, anemia or bleeding.

The company said Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells.

Amgen said data from the trial was consistent with the known safety profile of Aranesp and the adverse effects were generally balanced between those given the drug in the trial and those given a placebo. However, adverse effects such as fatigue, pyrexia, headache and myalgia were at least five percent more frequent than the placebo group.

Amgen last year reached a $71 million settlement with 48 U.S. states and the District of Columbia to resolve claims that it promoted Enbrel and Aranesp drugs for uses not approved by the U.S. Food and Drug Administration.

The company was accused by authorities of marketing Aranesp for off-label uses, such as to treat anemia caused by cancer.

Aranesp sales totaled $1.93 billion in 2014.

(Reporting by Kshitiz Goliya in Bengaluru; Editing by Bill Rigby)

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