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Amgen's Secondary Hyperparathyroidism Drug Approved in U.S.

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Amgen Inc. (AMGN - Free Report) announced that the FDA has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy in 12 years to be approved for this condition. The drug has to be administered intravenously thrice a week at the end of a dialysis session.

Amgen’s stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry in the last one month. Specifically, the company gained 5%, while the industry fell 1.4%.



The latest approval was supported by data from two placebo-controlled parallel phase III studies on chronic kidney disease (CKD) patients (n=1023) with sHPT (secondary hyperparathyroidism), which showed that Parsabiv met the primary endpoint and significantly reduced serum parathyroid hormone (PTH) levels — a key marker of sHPT.

We remind investors that in Nov 2016, the European Commission granted marketing approval to Parsabiv. The approval did not come as a surprise given that in September, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had rendered a positive opinion for the candidate. Moreover, in December, Amgen's partner, Ono Pharmaceuticals received manufacturing and marketing approval in Japan for Parsabiv for the same indication.

Note that, in Aug 2016, Amgen had received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv in this indication. The company later resubmitted the regulatory filing in the U.S. addressing the CRL.

Per the company’s press release, sHPT is a chronic and serious condition with approximately two million people throughout the world receiving dialysis, including 0.47 million in the U.S. Around 88% of dialysis patients are expected to develop sHPT. Hence, an approval will provide Parsabiv access to a large population of eligible patients.

We expect investors to focus on Amgen’s commercialization plans for Parsabiv.

Zacks Rank & Key Picks

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Eli Lilly and Company (LLY - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and GlaxoSmithKline plc (GSK - Free Report) . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Eli Lilly’s earnings estimates increased from $3.99 to $4.11 for 2016 and from $4.31 to $4.37 for 2017 over the last 60 days. Its share price increased 5.8% year to date.

Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.

GlaxoSmithKline’s earnings estimates increased from $2.52 to $2.53 for 2016 and from $2.64 to $2.66 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 8.96%. Its share price increased 2.5% year to date.

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