Amgen, Inc. AMGN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for its secondary hyperparathyroidism (SHPT) candidate Parsabiv (etelcalcetide).
Amgen is looking to get Parsabiv approved in the EU for the treatment of secondary hyperparathyroidism in adult chronic kidney disease (CKD) patients on dialysis. Amgen had submitted the Marketing Authorisation Application for Parsabiv last September.
The marketing authorization and the positive CHMP opinion were based on encouraging data from three phase III trials, including two placebo-controlled trials in more than 1,000 patients, and a head-to-head study comparing Parsabiv to Sensipar. All the three trials met their primary endpoints.
We note that Parsabiv is also under review in the U.S. In August, Amgen received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv in the indication. The company is currently reviewing the letter and expects to meet with the agency later this year to discuss the next step.
Parsabiv became part of Amgen’s portfolio following its Jul 2012 acquisition of privately held KAI Pharmaceuticals.
SHPT, a chronic and serious condition, is estimated to affect two million individuals in the world who receive dialysis. Approximately 88% of dialysis patients and 79% of patients on hemodialysis are expected to develop SHPT.
In a separate press release, Amgen and partner UCB S. A. UCBJF announced that data from the phase III FRAME study were published in the New England Journal of Medicine and were also presented at a medical meeting in Atlanta. Results from the FRAME study, which evaluated Amgen’s romosozumab for the treatment of postmenopausal women with osteoporosis, were announced this February. In July, Amgen and UCB submitted a Biologic License Application to the FDA seeking an approval in this indication based on the data from the study.
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Geron Corporation GERN and ANI Pharmaceuticals, Inc. ANIP. Both these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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