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FDA OKs Novel Calcimimetic for Secondary Hyperparathyroidism

Miriam E. Tucker

February 08, 2017

The US Food and Drug Administration (FDA) has approved the novel calcimimetic etelcalcetide (Parsabiv, Amgen) for the treatment of
secondary hyperparathyroidism in adults on hemodialysis.

Etelcalcetide is the first drug in 12 years to be approved for the condition, which affects approximately 88% of patients on dialysis and
79% on hemodialysis. It occurs when the parathyroid glands excessively secrete parathyroid hormone (PTH) in response to decreased
renal function and impaired mineral metabolism.

Etelcalcetide reduces the PTH level by binding to and activating the calcium-sensing receptor on the parathyroid gland. It offers an
advantage over the current standard calcimimetic treatment, cinacalcet (Sensipar, Amgen), in that it can be administered intravenously by
the dialysis healthcare team at the end of each hemodialysis session.

"The ability to provide my patients with an intravenous calcimimetic and help ensure they receive the therapy they need is a tremendous
milestone in the management of this frequently undertreated chronic progressive disease," said Geoffrey A. Block, MD, from Denver
Nephrology in Colorado, who is the lead researcher on two studies (one a two-part pivotal trial) of etelcalcetide published in JAMA in
January 2017.

"As a physician who cares for patients with advanced chronic kidney disease, I understand the importance of achieving and maintaining
simultaneous reductions in a number of complex lab values in the treatment of secondary [hyperparathyroidism]," Dr Block added.

The approval was based largely on the results from the two 26-week randomized, double-blind, phase 3, placebo-controlled pivotal trials,
which enrolled a total of 1023 hemodialysis patients with moderate to severe secondary hyperparathyroidism (PTH > 400 pg/mL).

Patients received intravenous etelcalcetide or placebo at the end of their thrice-weekly dialysis sessions, in addition to standard care that
could include administration of vitamin D and /or phosphate binders.

Both studies met the primary endpoint, with 77% and 79% of patients achieving 30% PTH reduction from baseline during weeks 20 to 27
in the first and second studies, compared with 11% with placebo in both studies, and PTH levels of 300 pg/mL or less, which was
achieved by 52% and 56% of patients, respectively, vs just 6% and 5% for patients receiving placebo.

Adverse events in the two studies combined included more frequent asymptomatic reductions in serum calcium levels and symptomatic
hypocalcemia with etelcalcetide compared to placebo. Other adverse events – none of which occurred in more than 12% of patients ―
included muscle spasms, diarrhea, nausea, vomiting, headache, and parathesia/hypoesthesia.

On the basis of doses expected to be used in clinical practice, the monthly costs of Parsabiv and Sensipar should be comparable, Amgen
said in the statement. "Amgen is committed to working with patients, dialysis providers and payers to deliver value-based solutions for
managing the burden of secondary [hyperparathyroidism]."

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Cite this article: FDA OKs Novel Calcimimetic for Secondary Hyperparathyroidism - Medscape - Feb 08, 2017.

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