FDA Mulling Once-Monthly Anemia Drug

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The FDA is reviewing a New Drug Application for peginesatide as a treatment for anemia associated with chronic renal failure in adult dialysis patients.

If approved, the drug would be the first once-monthly option for this patient population. Phase 3 trial data showed that once-monthly administration of peginesatide was similar to epoetin given up to 13 times a month in maintaining hemoglobin levels over time and with a similar adverse event rate.

Peginesatide is a synthetic PEGylated peptide-based compound that binds to and activates the erythropoietin receptor. Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceutical Co., Ltd, of Osaka, Japan, have collaborated in the development of the drug.

One of the peginesatide investigators, Steven Fishbane, MD, said peginesatide, if approved, would benefit dialysis centers and patients. “By having a drug that has proven to be similar in efficacy [to epoetin] yet given just once a month, you have a really important convenience,” said Dr. Fishbane, Professor of Medicine at the State University of New York at Stony Brook. Nurses could spend much less time giving injections to anemic dialysis patients, freeing them up to focus on providing quality care, including safety and patient education. The ability to offer patients once-monthly dosing of an erythropoiesis-stimulating agent gives dialysis units flexibility in how nurses spend their time there, potentially fostering a cost-saving efficiency that could be advantageous under Medicare's new system of bundled payments to dialysis providers, Dr. Fishbane noted.

In addition, peginesatide could prove valuable as an alternative for patients who develop antierythropoietin antibodies, thus rendering epoetin and patients' own erythropoietin ineffective, he pointed out. In a study of 14 European patients with this condition, Ian C. Macdougall, MD, of King's College Hospital in London, and colleagues showed that peginesatide, which is structurally different from erythropoietin and its analogues, can be used successfully as rescue therapy to correct anemia.

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