FDA Approves Treatment for Adults with Secondary Hyperparathyroidism on Hemodialysis

The FDA has greenlighted Amgen’s Parsabiv (etelcalcetide) as the first therapy in 12 years approved to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv can be administered intravenously to the patient 3 times a week at the end of each hemodialysis session.

The approval is based on data from 2 clinical trials, which demonstrated that patients achieved greater than 30% reduction from baseline in parathyroid hormone (PTH) levels during the efficacy assessment phase. Parasabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, which allows it to decrease PTH levels.

“Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the health care professional,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a press release.

Parsabiv is not recommended for use in patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis. The most common adverse reactions include blood calcium decrease, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.

Reference

FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis [news release]. California. Amgen’s website. http://www.amgen.com/media/news-releases/2017/02/fda-approves-amgens-parsabiv-etelcalcetide-first-new-treatment-in-more-than-a-decade-for-secondary-hyperparathyroidism-in-adult-patients-on-hemodialysis/. Accessed Feb. 8, 2017.