Amgen Pediatric Trials of Sensipar Halted by FDA After Death
U.S. regulators halted Amgen Inc. (AMGN)’s pediatric clinical trials of the kidney drug Sensipar after a 14-year-old patient died.
Sensipar, approved in adults in 2004, was being tested for effectiveness and safety in children younger than 18 years old, the Food and Drug Administration said today in a statement. The FDA said it hasn’t concluded whether Sensipar had a role in the death and will make recommendations when its review is complete.
Amgen, the world’s largest biotechnology company, generated $950 million in sales last year from Sensipar, or about 5.5 percent of its total sales, according to data compiled by Bloomberg. Sensipar works by lowering levels of a hormone to reduce calcium in the blood.
“Amgen is working as rapidly as possible to understand the circumstances of what happened,” Ashleigh Koss, a spokeswoman for the Thousand Oaks, California-based company, said in an e- mail. “This analysis is ongoing and will be concluded as quickly as possible.”
Three pediatric studies for Sensipar dating to 2010 are listed on the National Institutes of Health’s website clinicaltrials.gov.
The most frequently reported side effects in adult clinical trials of Sensipar were nausea, vomiting and diarrhea, the FDA said.
Amgen declined less than 1 percent to $86.51 at 12:50 p.m. New York time. The shares gained 32 percent in the 12 months through yesterday.
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