Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nasdaq  >  Amgen, Inc.    AMGN

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Amgen, Inc. : Amgen : FDA Letter Rejects Expanded Use Of Xgeva For Prostate Cancer

share with twitter share with LinkedIn share with facebook
share via e-mail
0
04/27/2012 | 01:22pm CEST

Amgen Inc. (AMGN) received a complete response letter from the U.S. Food and Drug Administration rejecting the expanded use of Xgeva in men with prostate cancer that hasn't spread to the bones.

According to the drug maker, the FDA letter said the agency can't approve the supplemental biologics license application in its present form because the effect on bone metastases-free survival doesn't outweigh the risks, such as osteonecrosis of the jaw, a rare jaw-decay problem.

"We are reviewing the complete response letter and will work with FDA to determine any next steps," said Sean E. Harper, executive vice president of research and development.

Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancer has already spread to the bones. It is also sold under the brand name Prolia as an osteoporosis treatment, but is administered at a lower dose. Xgeva's and Prolia's combined sales in 2011 topped $550 million.

A federal advisory panel in February rejected Amgen's proposal to expand the bone drug's use, saying it was unclear whether the results were clinically meaningful.

Amgen's study of Xgeva in men with prostate cancer that hadn't responded to previous therapies, but hadn't yet spread to the bones showed the drug prolonged median bone metastatis-free survival by 4.2 months.

Shares closed Thursday at $70.79 and were inactive premarket. The stock it up 10% so far this year.

-By Melodie Warner, Dow Jones Newswires; 212-416-2283; [email protected]

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on AMGEN, INC.
05/26 Khang & Khang LLP Announces an Investigation of Amgen Inc. and Encourages Inv..
05/26 GLANCY PRONGAY & MURRAY LLP : Commences Investigation on Behalf of Amgen Inc. In..
05/24 AMGEN : Health and Human Services Department (HHS); Food and Drug Administration..
05/23 Lundin Law PC Announces an Investigation of Amgen Inc. and Advises Investors ..
05/23 Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Amgen Inc. (AMG..
05/23 NEUROPACE : Develops and markets implantable devices for the treatment of neurol..
05/23 AMGEN, INC. : Blog Coverage: Amgen Announces New Data from the FOURIER Trial
05/23 AMGEN : shares fall as it reveals new cardiovascular risks for its Evenity osteo..
05/22 Goldberg Law PC Announces an Investigation of Amgen Inc.
05/22 AMGEN INC : Change in Directors or Principal Officers, Submission of Matters to ..
More news
Sector news : Bio Therapeutic Drugs
05/23 UK competition watchdog accuses Merck of obstructing biosimilars
05/22 Cross-border M&A between U.S. and European firms at 10 year high
05/09 Sanofi pegs U.S. drug price rises to below healthcare inflation
05/09DJVERTEX PHARMACEUTICALS INCORPORATED : Trump's Pick to Lead FDA Has Backing of Bi..
05/07 REGENERON SHARES POISED FOR REBOUND : Barron's
More sector news : Bio Therapeutic Drugs
News from SeekingAlpha
05/27 3 THINGS IN BIOTECH YOU SHOULD LEARN : May 27, 2017
05/26 Renal Cancer Data For Acceleron's And Coherus' Biosimilars' Date With The FDA
05/25 FDA advisory committee backs Pfizer's Epogen biosimilar
05/25 FDA drug approvals rebound from last year, up over 100% yoy
05/25 Ad Comm review today for Pfizer's biosimilar to Amgen's Epogen
Advertisement
Financials ($)
Sales 2017 22 644 M
EBIT 2017 11 765 M
Net income 2017 8 141 M
Finance 2017 1 258 M
Yield 2017 2,92%
P/E ratio 2017 14,05
P/E ratio 2018 13,90
EV / Sales 2017 4,98x
EV / Sales 2018 4,40x
Capitalization 113 994 M
More Financials
Chart AMGEN, INC.
Duration : Period :
Amgen, Inc. Technical Analysis Chart | AMGN | US0311621009 | 4-Traders
Full-screen chart
Technical analysis trends AMGEN, INC.
Short TermMid-TermLong Term
TrendsBearishNeutralNeutral
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 24
Average target price 182 $
Spread / Average Target 18%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Robert A. Bradway Chairman & Chief Executive Officer
Esteban Santos Executive Vice President-Operations
David W. Meline Executive VP, Chief Financial & Accounting Officer
Sean E. Harper Executive Vice President-Research & Development
Paul R. Eisenberg Chief Medical Officer & Senior VP-Global Medical
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
AMGEN, INC.6.02%113 994
CELGENE CORPORATION0.89%91 185
GILEAD SCIENCES, INC.-9.93%84 284
REGENERON PHARMACEUTIC..23.99%48 380
ACTELION LTD24.38%30 559
VERTEX PHARMACEUTICALS..62.78%29 868
More Results