Navigation Links
XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
Date:7/15/2011

THOUSAND OAKS, Calif., July 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies.

Bone metastases, the spread of cancer to the bones, are a common and serious concern for patients with advanced cancer and present a burden to the healthcare system. Weakened bones due to metastases can lead to SREs. The primary goal of treatment for bone metastases is to prevent the occurrence of these debilitating and costly SREs.

"Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today's approval of XGEVA marks a real advance," said Professor Ingo J. Diel, M.D., Institute for Gynecological Oncology, SPGO, Mannheim, Germany. "In clinical trials XGEVA demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer."

The marketing authorization for XGEVA is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs. The SRE clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients. In the SRE trials, XGEVA demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid. In these trials, XGEVA was administered every four weeks as a 120 mg subcu
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
2. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
3. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
4. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
5. The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
6. XGEVA™ (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer
7. Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
8. Prolia™ (denosumab) Receives Best New Drug Honor at Scrip Awards
9. China Botanic Pharmaceutical Granted China Patent for Siberian Ginseng Extraction Process
10. ACT Granted EU Orphan Medicinal Product Designation for hESC-Derived RPE Cells for Treatment of Stargardts Disease
11. ViroPharmas Cinryze® (C1 Inhibitor [Human]) Granted European Marketing Authorization for Hereditary Angioedema (HAE)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... 17, 2013  Orexigen® Therapeutics, Inc. (Nasdaq: OREX ... at the UBS Global Healthcare Conference in New ... 22 nd at 11 a.m. Eastern Time. To listen ... please visit the Investor Relations section of the Company,s Web ... for 14 days after the event. About Orexigen® ...
(Date:5/17/2013)... Mass., May 17, 2013   Shareholder rights attorneys ... Aveo Pharmaceutical, Inc. (NASDAQGS: AVEO) securities has filed a ... of Massachusetts .  The complaint alleges ... Securities Exchange Act of 1934 (the "Exchange Act") between ... Period"). (Logo: http://photos.prnewswire.com/prnh/20130103/MM36754LOGO ) ...
(Date:5/17/2013)... , May 17, 2013  Sony Biotechnology Inc. ... SP6800 Spectral Analyzer (SP6800).  Sony will be exhibiting and ... will be held at the San Diego ... California , from May 20 - 22.  ... analytical system, incorporating commercial audio-visual technologies into new and ...
Breaking Medicine Technology:Aveo Pharmaceuticals, Inc. Sued by Investor 2Aveo Pharmaceuticals, Inc. Sued by Investor 3Sony Biotechnology Inc.'s New Technology for Science Provides Researchers Results in Color 2
(Date:5/18/2013)... a few extra cups of coffee each month might ... known as primary sclerosing cholangitis (PSC), a new study ... Minn., found that drinking coffee was associated with a ... to cirrhosis of the liver, liver failure and biliary ... relationship. "While rare, PSC has extremely detrimental ...
(Date:5/18/2013)... a May 14, 2013 article entitled “Angelina Jolie Reveals ... Fox News reported the movie star had opted to ... gene that doctors estimated gave her an 87 percent ... of ovarian cancer (go to: goo.gl/5JHBP). Ms. Jolie’s personal ... blog post entitled “A Patient’s Journey: Angelina Jolie” that ...
(Date:5/18/2013)... May 18, 2013 The Communities of ... special places we call home. These are the townships, villages ... are the locations where the people are friendly and neighbors ... viewers off the highways and shares the best in both ... nations with an American sports and film celebrity. It airs ...
(Date:5/18/2013)... Washington DC (PRWEB) May 18, 2013 Family ... Best" designation for excellence by Follow Media Consulting, Inc. in ... award signifies the continued commitment and dedication of the areas ... lifestyle. , No one knows parenting better than Brenda Hyde, ... goal is to help parents know about the vast resources ...
(Date:5/18/2013)... (PRWEB) May 18, 2013 The “Sleep ... Pulse Oximeters, CPAP, Masks, Adaptive Servo-Ventilation (ASV), Oral Appliances, ... Forecast to 2017” analyzes and studies the major market ... and Rest of the World. , Browse , ... 16 Figures , 318 ...
Breaking Medicine News(10 mins):Health News:Study Links Coffee to Lower Risk for Rare Liver Disease 2Health News:Angelina Jolie – Scarless Breast Augmentation Surgery 2Health News:Communities of Distinction TV Presents "A Place to Call Home" Segment 2Health News:Summer Camps in DC "Best of the Best" Awarded to Family Magazine of Washington DC for Excellence by Follow Media Consulting, Inc. 2Health News:Sleep Apnea Devices Market to reach $19.72 Billion by 2017 - New Report by MarketandMarkets 2Health News:Sleep Apnea Devices Market to reach $19.72 Billion by 2017 - New Report by MarketandMarkets 3
... by aiding in senior health and ... ... in market research for the health insurance industry, today,announced the release of ... and over population. SrHRA provides,proven health risk stratification measures based on self-reported,information ...
... ... benefits plans, COLUMBIA, S.C., Jan. 9 One of ... and a clearer message.,Colonial Life & Accident Insurance Company today ... who the company is and what it,does., (Logo: ...
... Expected results include higher quality care, increased ... Group Health Incorporated (GHI) and,Health Plan of New York ... first of its kind in New York, that will provide ... to become Medical,Home Practices. GHI and HIP see this as ...
... Diego, January 8, 2008 ?Eating out instead of cooking ... the American diet. Americans face a large variety of ... out. Do the choices of available restaurants matter ... the February 2008 issue of the American Journal of ...
... could improve understanding of irritable bowel syndrome and lead ... News) -- Women with irritable bowel syndrome anticipate and ... new study suggests. , The University of California, ... effectively switch off a pain modulation mechanism in the ...
... Reduce Stiffness for Better Health with,Innovative ,Sleep and ... FORT LAUDERDALE, Fla., Jan. 9 Contour ... people implement an,ergonomic makeover into their life for ... well being. By aligning the body, relieving,pressure points ...
Cached Medicine News:Health News:DSS Research Announces Senior Health Risk Assessment Tool 2Health News:New Colonial Life Brand Clarifies Company's Strengths 2Health News:New Colonial Life Brand Clarifies Company's Strengths 3Health News:GHI and HIP Launch Pilot Medical Home Network Project with Support from Commonwealth Fund 2Health News:GHI and HIP Launch Pilot Medical Home Network Project with Support from Commonwealth Fund 3Health News:Eating out can have both positive and negative impact on obesity 2Health News:Women With IBS Unable to Switch Off Pain Response 2Health News:Renew, Relax & Align the Body with an Ergonomic Makeover 2Health News:Renew, Relax & Align the Body with an Ergonomic Makeover 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: