Amgen Drug Promising for Bone Marrow Disorder

Jul. 7–An anemia-fighting drug from Amgen Inc. shows promise in early studies for patients who suffer from a bone-marrow disorder.

At a symposium in Geneva on Wednesday, the Thousand Oaks company announced positive interim results for patients with anemia who have myelodysplastic syndromes (MDS) treated with its drug Aranesp. Patients with MDS, also known as pre-leukemia, do not produce enough blood cells in their bone marrow.

The study results show that 77 percent of patients who had not been treated with a similar drug before responded to Aranesp. Patients had increases in hemoglobin, or red blood cell, levels and less fatigue after receiving Aranesp every three weeks.

Aranesp already is used to treat anemia in patients with chronic kidney disease and patients undergoing chemotherapy for certain cancers. Anemia is a result of low red blood cell counts.

“The majority of MDS patients develop clinically significant anemia during the course of their disease, which often leads to fatigue and increased red blood cell transfusions,” said Dr. Janice Gabrilove, the study’s lead investigator and professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine in New York.

The study is testing the drug in a group of patients with the disease for efficiency. The interim data is based on about 13 weeks of data from 100 patients with MDS who had a low risk of developing acute myeloid leukemia.

Of patients who had not received anemia treatment through a drug like Aranesp, 77 percent responded to the treatment, with 47 percent showing a major response. Patients who had previous treatment continued to respond to the Aranesp therapy, with 21 percent showing a major response.

Sixteen percent of patients experienced serious side effects, including anemia, neutropenia, a decline in a type of white blood cell, and chest pain.

The FDA has not approved recombinant erythropoietic products, such as Aranesp, to treat anemia in MDS patients. The drug will have to continue to show positive results in larger studies before an application can be submitted to the FDA.

Amgen has eight drugs on the market, two of which have received multiple approvals.

Amgen’s stock rose $1.09 to close at $63.60 Wednesday.

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