The Food and Drug Administration (FDA) on Tuesday approved a new drug called Omontys (peginesatide). This is expected to topple Amgen Inc. from its near monopoly in the roughly $6 billion U.S. anemia treatment market.
Omontys, developed by Affymax Inc. of Palo Alto, was approved for use by adult dialysis patients with anemia caused by chronic kidney disease. There are about 400,000 U.S. kidney disease patients on dialysis. It belongs to a class of drugs called erythropoiesis-stimulating agent (ESA) that helps in formation of red blood cells. It stimulates the bone marrow to produce more red blood cells and reduces the need for transfusions in patients with CKD.
It is to be injected monthly, which gives it an advantage over Amgen’s anemia drug for chronic kidney disease, Epogen, which generally is administered three times a week. Epogen, approved in 1989, is the Thousand Oaks biotech’s oldest product and had sales of about $2 billion last year.
Omontys “offers patients and health care providers the convenience of receiving (anemia) therapy just once per month instead of more frequent injections,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, in a statement.
“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Padzur. The safety and efficacy of Omontys was found in two randomized, active-controlled, open-label, multi-center clinical trials. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current epoetin treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter. The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were vomiting, diarrhea, high blood pressure and joint, back, leg or arm pain.
“We have suffered under a monopoly now for many years, and Amgen has done pretty much whatever they’ve pleased,” said Dr. John H. Sadler, chief executive of the Independent Dialysis Foundation, a small nonprofit dialysis provider in Baltimore. The prices dialysis providers negotiate with Amgen help determine their profitability, he and other dialysis industry executives say. Without competition, Amgen has been free to set prices and recently raised them significantly, according to some of the executives.
John A. Orwin, chief executive of Affymax, which is based in Palo Alto, Calif., said there was still a substantial market in midsize and small dialysis providers. “There’s a group of people who are very anxious to talk to us,” he said in an interview this month. Takeda, the big Japanese drug company, will help market Omontys.
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