Amgen Inc. has applied to the Food and Drug Administration for permission to sell etelcalcetide, a treatment for an ailment found in patients on dialysis, the company announced Tuesday.
The Thousand Oaks biotech said the drug treats hyperparathyroidism, which is linked to higher risks for stroke, heart attach and cancers and is common among patients who need dialysis because of chronic kidney disease. The condition affects about 2 million people worldwide, including 450,000 in the United States.
“We look forward to working with regulatory authorities during the review process to bring this important treatment to market, helping to fill an unmet need,” Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement.
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