* FDA does not know if Sensipar had role in patient death
* Drug approved for adults to remove calcium from blood
Feb 26 The U.S. Food and Drug Administration
said on Tuesday it has stopped all pediatric clinical trials of
Amgen Inc's Sensipar after the death of a 14-year-old
patient taking part in a study of the drug.
Sensipar, which is approved for adults, is used to lower
dangerously high calcium levels in the blood.
The agency said it was collecting information on the
circumstances of the teenager's death. It said it does not know
if the Amgen drug had any 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 posted on its
Amgen, the world's largest biotechnology company, said it
had sent a letter last week to healthcare providers alerting
them to the trials' halt and the patient death.
"Amgen is working as rapidly as possible to understand the
circumstances of what happened. This analysis is ongoing and
will be concluded as quickly as possible," the company said in a
Sensipar works by decreasing the release of parathyroid
hormone from the parathyroid gland to lower calcium levels in
the blood. High levels of calcium in the blood can lead to
serious health problems.
Sensipar, which had worldwide sales of $950 million in 2012,
is approved to treat adults 18 and over. The trials were being
conducted to determine the safety and efficacy of the drug in
Drugmakers also often conduct pediatric trials because they
are rewarded with an additional six months of patent protection
for testing medicines in children.