FDA Suspends Amgen Drug TrialTuesday, February 26, 2013
The Food and Drug Administration has suspended pediatric trials of Amgen Inc.’s thyroid drug Sensipar following the death of a 14-year-old trial patient, the agency said Tuesday.
The drug is already on the market for adult use to treat secondary hyperparathyroidism – which can cause fatigue, weight loss and goiters – in patients with chronic kidney disease on dialysis; elevated calcium levels levels in patients with parathyroid carcinoma; and elevated calcium levels in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.
“(The) FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and the clinical trials were underway to determine if the drug is effective and can be safely used in children,” the agency said in a statement.
While the FDA said it has not conclusively linked the child’s death with Sensipar, it is halting trials while it investigates the patient’s death. It also noted that the drug may lower calcium levels too low, resulting in health problems.
A spokesperson for the Thousand Oaks biotech told Bloomberg News via email that the company will work with the FDA to find out whether the drug caused the death. The company also said in a statement that it had informed physicians involved in the trial about the suspension last week.
Several trials of the drug have been underway in the last year, with the company looking to add approved uses to bolster sales.
Shares of Amgen were up 8 cents, or less than 1 percent, to $89.63 in midday trading on the Nasdaq.