Amgen’s injectable calcimimetic, Parsabiv™ (etelcalcetide), was approved by the FDA for treating secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) who are receiving hemodialysis. Amgen currently markets its Sensipar®/Mimpara® (cinacalcet) tablets in the U.S. and other markets for the same indication. The firm says Parsabiv is the first therapy to be approved for the secondary HPT indication in 12 years. The treatment is also the only calcimimetic that can be administered intravenously by dialysis healthcare professionals. Patients receive the treatment three times a week at the end of their hemodialysis session.
“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 healthcare professional,” commented Sean E. Harper, M.D., evp of Research and Development at Amgen. Geoffrey A. Block, M.D., nephrologist at Denver Nephrologists, in Colorado, added, “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.”
Approval of Parsabiv in the U.S. was based on data from Phase III studies in more than 1,000 hemodialysis patients with moderate to severe secondary HPT. Patients received either Parsabiv or placebo three times a week after hemodialysis, in addition to standard of care. The two studies showed that nearly 80% of patients receiving Parsabiv achieved a greater than 30% reduction from baseline in parathyroid hormone (PTH) during the assessment phase of the studies, compared with only 11% of patients receiving placebo. The two trials also confirmed that while greater than 50% of Parsabiv-treated patients achieved PTH levels of 300 pg/mL or less, only 5–6% of patients receiving placebo achieved the same reduction. Pooled analyses from the two studies showed that patients treated using Parsabiv more frequently demonstrated asymptomatic reductions in serum calcium (64% Parsabiv vs. 10% placebo) and symptomatic hypocalcemia (7% vs. 0.2% placebo).
Sensipar/Mimpara was Amgen's fifth biggest-selling drug in 2016, achieving sales of nearly $1.6 billion in 2016, up 12% on 2015 figures. Sales of the drug in Q4 2016 were $411 million, up 7% on Q4 2015 sales. Amgen’s recently reported Q4 and full-year 2016 results included a 6% increase in full-year revenues, which reached $23 billion, and sales growth of 5%. Sales of the firm's biggest seller, Enbrel (etanercept), were up 14% in Q4 2016, compared with Q4 2015, and reached $6 billion for the full 2016 year, up 11% on 2015.