Time New York: Sun 25 Sep 08:20 am  |  Save 15% on H&R Block Online

  
caticonslite_bm_alt

Amgen (AMGN) Parsabiv Gets Positive CHMP Opinion in EU

Zacks

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.


AMGEN INC Price and Consensus

AMGEN INC Price and Consensus | AMGEN INC Quote

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.

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research
<-- You can share this post with your network,
or give us your opinion and leave a comment.
Be sure to check our RSS feeds for updates.

RSS Feeds to WordPress Posts