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The Food and Drug Administration has stopped pediatric trials of Amgen Inc's Sensipar after a 14-year-old patient died.
Amgen, the world's largest biotechnology company, is investigating the death of a child who took its Sensipar drug. The United States Food and Drug Administration announced today that as a result, it has suspended pediatric trials of Sensipar. The drug is already on the market to treat adults for hyperthyoidism, the San Fernando Valley Business Journal reported. But Amgen was testing the drug to see if it would also work for children.
That ended when a 14-year-old patient participating in the drug trial died. Sensipar has already generated $950 million in sales for Amgen,Bloomberg News reported.
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“Amgen is working as rapidly as possible to understand the circumstances of what happened,” Ashleigh Koss, a spokeswoman for Amgen, told Bloomberg. “This analysis is ongoing and will be concluded as quickly as possible.”
The FDA says that it is also investigating to see if the drug trial and the child's death are related. The FDA does not know yet if Amgen's drug is responsible for the death,Reuters reported.
Drug makers often conduct drug trials on children because doing so awards them with six extra months of patent protection, Reuters says.