FDA Stops Pediatric Drug Trials of Amgen after 14 year-old Dies
The Food and Drug Administration (FDA) has officially ended the drug trial of Amgen Inc's drug, Sensipar after a 14 year-old participant of the trial died on Tuesday. Whether or not the trial will be restarted will depend on the FDA's findings. Sensipar is an approved drug on the market for adults with elevated amounts of calcium present in their bloodstream. An extremely high level of calcium, known as hypercalcemia can cause symptoms such as pain, vomiting, nausea, and frequent urination. If left untreated, hypercalcemia can lead to other health complications.
Although the reason behind the death of the 14 year-old patient is still unknown, the FDA does not want to risk continuing the drug trial for the safety of the other patients. The FDA stated that "this communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when out review is complete." With that said, the future of the drug trial rests solely in the FDA's hands.
Amgen is the world's biggest biotechnology company. Its drug, Sensipar earned $950 million from global sales in 2012 alone. Since hypercalcemia usually results from parathyroid complications, the drug works by decreasing the release of the parathyroid hormone from the gland. Sensipar acts as a monitor of the gland and prevents high levels of calcium from building up in the bloodstream. Although the drug has been widely successful among adults, it had not been proven to be effective for young children, which was the purpose for the trial.
"Amgen is working as rapidly as possible to understand the circumstances of what happened," the company commented. "This analysis is ongoing and will be concluded as quickly as possible."
In the meantime, the company and the trial await results from the investigation into the death of the teenager.