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FDA Stops Pediatric Trials Of Amgen's (AMGN) Sensipar After Death

 February 26, 2013 01:24 PM
 


(By Balachander) The U.S. Food and Drug Administration (FDA) has stopped all pediatric clinical trials of Amgen Inc.'s (NASDAQ: AMGN) Sensipar after the death of a 14-year-old patient in a trial.

Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis.

The U.S. health regulator said it continues to gather information on the circumstances surrounding the patient's death. The FDA said it has not  concluded whether or not Sensipar had a role in the death.

"This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete," the FDA said in a statement.

[Related -Amgen, Inc. (NASDAQ:AMGN): What Will Drive Amgen This Year?]

The FDA has approved Sensipar, which lowers calcium levels in the blood, for use in adults in 2004. Clinical trials were conducted to determine if the drug is effective and can be used safely in children (less than 18 years of age).

"Amgen is working as rapidly as possible to understand the circumstances of what happened," Bloomberg reported quoting an e-mail from Amgen spokeswoman Ashleigh Koss.

Amgen generated sales of $950 million from Sensipar last year, according to a Bloomberg data.

Amgen shares traded 0.06 percent lower at $89.52 at 1.22 pm ET on Tuesday.

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