Amgen files for approval of parathyroid disorder drug
NEW YORK (AP) — Biotech drugmaker Amgen said Tuesday it filed for marketing approval of a drug designed to treat a symptom of chronic kidney disease.
Amgen asked the Food and Drug Administration to approve its drug etelcalcetide as a treatment for secondary hyperparathyroidism, a condition that can cause fragile bones, pain, and organ damage. The drug is intended for patients who have chronic kidney disease and are on dialysis. It would be given three times a week at the end of their dialysis sessions.
Chronic kidney disease often causes levels of calcium and phosphorous in the body to drop. In response, the parathyroid glands in the neck can start producing too much parathyroid hormone, a chemical that controls the levels of calcium and phosphorous and vitamin D in blood and bone. The parathyroid hormone takes calcium out of the bones so it can be reabsorbed into the body. The high levels of calcium in the blood can cause organ damage, while the depleted bones are more likely to break.
Other symptoms of hyperparathyroidism include bone pain and tenderness, forgetfulness and depression.
The Thousand Oaks, California-based company already makes one drug designed to treat the condition. That drug, Sensipar, is a pill taken once a day. Amgen says that can be a problem because patients with chronic kidney disease already have to take a significant number of pills.
The company reported $344 million in revenue from Sensipar in the second quarter, up 15 percent from a year ago.
Shares of Amgen Inc. rose $4.16, or 2.8 percent, to $151.79 Tuesday afternoon as the broader markets rallied from a steep three-day slump.