FDA yesterday halted Amgen’s pediatric clinical trials for its thyroid drug Sensipar® (cinacalcet hydrochloride), following the death of a 14-year-old patient during one trial.
The agency sent a letter to healthcare professionals stating it is investigating the circumstances of the patient’s death, while stressing it had not yet come to a conclusion about Sensipar’s role in that death. The agency promised it “will communicate our final conclusions and recommendations when our review is complete.”
The 14-year-old died during a trial to assess whether Sensipar can be used safely and effectively in minors under 18 years of age. Of three Amgen-sponsored pediatric trials of the drug listed on Clinicaltrials.gov as recruiting patients, only one was recruiting patients as old as the victim—a Phase III trial assessing Sensipar’s safety and efficacy in pediatric patients ages 6–17 with chronic kidney disease, for which information was updated this month. That study had an estimated Primary Completion Date, entailing final data collection for the primary outcome measure, of November 2014, with the study estimated to be completed in September 2015.
The two other Amgen-sponsored pediatric trials for the drug involved patients ages 28 days to 6 years. A Phase II trial, with data updated this month, will assess Sensipar’s safety and tolerability in pediatric patients with chronic kidney disease and secondary hyperparathyroidism. Estimated completion date for that study is February 2016.
Information was last updated in July for a third Amgen-sponsored pediatric trial, a Phase I study to evaluate safety and tolerability of the drug in pediatric subjects 28 days to up to 6 years of age with chronic kidney disease receiving dialysis. Completion date estimated for that study is November 2013.
In past adult clinical trials, the most frequently reported side effects of Sensipar were nausea, vomiting, and diarrhea, according to FDA.
Sensipar is a calcium-sensing receptor agonist indicated in adults for:
- Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
- Hypercalcemia in patients with parathyroid cancer
- Severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy
“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 statement.
Launched in 2004 and sold in some countries under the brand name Mimpara®, Sensipar racked up $256 million in fourth-quarter sales last year, up 19% from Q4 2011, and $950 million in sales for all of 2012, up 18% from the previous year. Amgen credited the sales gains to increases in units sold, and in the price of the drug.
News of the Sensipar trial death did not appear to shake investor confidence in Amgen stock, as shares of the biotech giant finished trading yesterday at $89.47, down only 8 cents from Monday. Over the past year, the price of Amgen shares has risen more than 30%.