Navigation Links
Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
Date:5/20/2011

p>

Overall rates of adverse events and serious adverse events were generally similar between XGEVA and Zometa. Osteonecrosis of the jaw (ONJ) was infrequent, with no statistically significant difference between treatment arms. Hypocalcemia was more frequent in the XGEVA treatment group. Overall survival and progression-free survival were similar between arms in all three trials.

XGEVA Regulatory Status

XGEVA is currently approved in the United States (U.S.) for the prevention of SREs in patients with bone metastases from solid tumors.  XGEVA was approved following a six month priority review by the U.S. Food and Drug Administration (FDA). In the U.S., XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.(i)   XGEVA is also approved in Canada for reducing the risk of developing SREs in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors.  In Canada, XGEVA is not indicated for reducing the risk of developing SREs in patients with multiple myeloma.

Amgen has also submitted marketing applications for XGEVA in Australia, Mexico, Russia and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited and a marketing application was submitted in August. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

ONJ can occur in patients receiving XGEVA. Patients who are
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Arthritis Foundation Announces Amgen and Wyeth to Be Presenting Sponsor of the 2008 Arthritis Walk (R)
2. Medarex to Receive Milestone Payment from Amgen
3. AMT Obtains License to Amgens GDNF Gene to Develop Treatment for Parkinsons Disease with AMTs Proprietary Gene Therapy Platform
4. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
5. CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients
6. Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
7. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
8. Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes
9. Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
10. Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
11. Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... -- Omeros Corporation (NASDAQ: OMER ) today announced that ... Inc. and its subsidiary, Par Sterile Products, LLC, (collectively ... of New Jersey and in ... Delaware . The lawsuits were filed under ... patents, U.S. Patent Nos. 8,173,707, 8,586,633 and 9,066,856, which ...
(Date:9/3/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/hs5hvr/investigation ... "Investigation Report on China Tamsulosin Market, 2010-2019" ... with other a1- adrenergic receptor blockers, tamsulosin hydrochloride ... risk of urinary tract infections and therefore is ... in 1993 in Japan , ...
(Date:9/3/2015)... BALTIMORE , September 3, 2015 ... that its subsidiary Lupin Pharmaceuticals, Inc. (Lupin) has ... which is the first and only generic Duloxetine ... strength. Lupin is excited to bring this new ... currently available dosing options for greater flexibility of ...
Breaking Medicine Technology:Omeros Files Infringement Suits Against Par 2Omeros Files Infringement Suits Against Par 3Omeros Files Infringement Suits Against Par 4China Tamsulosin Market Investigation Report 2015 2Lupin Launches First-ever Duloxetine 40mg Delayed-Release Capsules in the US 2Lupin Launches First-ever Duloxetine 40mg Delayed-Release Capsules in the US 3Lupin Launches First-ever Duloxetine 40mg Delayed-Release Capsules in the US 4
(Date:9/3/2015)... ... September 03, 2015 , ... TransPack Toon gives users ... can choose from wipes and framing transitions in 30 different styles. Presets range from ... Final Cut Pro X. , TransPack Toon features 90 cartoon transitions from 30 unique ...
(Date:9/3/2015)... York (PRWEB) , ... September 03, 2015 , ... William ... William Mattar, Esq. believes this does not stop at any certain demographic or ... to its newly produced one-minute, thirty-, fifteen- and ten-second TV commercials. , The closed ...
(Date:9/3/2015)... NH (PRWEB) , ... September 03, 2015 , ... ... new agreement with Amerinet Inc., a leading national healthcare solutions organization, to provide ... Epic EMR. , Through this agreement, Amerinet members will receive negotiated pricing on ...
(Date:9/3/2015)... South Bend, IN (PRWEB) , ... September 03, ... ... Mayo Clinic, Rochester, MN, and Indiana University, Indianapolis, have chosen Center for ... immediately, physicians from these institutions will train at CHC as part of fulfilling ...
(Date:9/3/2015)... ... September 03, 2015 , ... DriButts, a ... partnered with Slingshot® Product Development Group to manufacture a long-lasting reusable diaper for ... with DriButts plans to bring 600 DriButts Diapers to rural areas of Haiti ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Releases TransPack Toon, a New FCPX Transition 2Health News:Law Firm Focused on “Helping People” Continues to Expand on Vision 2Health News:E-Volve Health to Offer EMR Consulting Solutions to Amerinet Members 2Health News:Physicians from Mayo Clinic and Indiana University to Complete Hospice & Palliative Medicine Training at Center for Hospice Care 2Health News:DriButts Diapers Rely on Slingshot Help in Haiti 2Health News:DriButts Diapers Rely on Slingshot Help in Haiti 3
... , , WASHINGTON , ... (National Council) is offering small emergency grants and free Mental Health ... of the devastating Haiti earthquake. , "Our thoughts are ... ones in the U.S. We commend the efforts of many agencies ...
... that launch glioblastoma multiforme, the most lethal type of brain ... scientists from The University of Texas M. D. Anderson Cancer ... the Jan. 15 issue of Clinical Cancer Research . ... also known as cancer stem cells, stifles the immune response ...
... Long-term use of low-dose versions affect women most, study finds, ... decrease bone density in young women, a new study suggests. ... years, and those on the low-dose estrogen pills appear to ... spine and whole body, according to the researchers. , "I ...
... Irritable bowel syndrome (IBS) is a common gastrointestinal ... well being. Multiple interacting mechanisms, including alterations in ... IBS aetiology. A research article to be ... World Journal of Gastroenterology addresses this question. ...
... increasing worldwide and its prognosis is very poor. ... early detection and on surgical treatment for better ... team from China retrospectively evaluated 5311 liver cancer ... December 2003. Of these, 429 (8.1%) patients were ...
... ... the new year by expanding their existing Green Bay, WI presence with the purchase ... ... technology company representing both businesses and residents has joined forces with Buildmyownsite, Inc., a ...
Cached Medicine News:Health News:Emergency Grants and Mental Health First Aid Training Available to Meet Mental Health Needs After Haiti Earthquake 2Health News:Emergency Grants and Mental Health First Aid Training Available to Meet Mental Health Needs After Haiti Earthquake 3Health News:Cancer stem cells suppress immune response against brain tumor 2Health News:Cancer stem cells suppress immune response against brain tumor 3Health News:The Pill May Decrease Bone Density 2Health News:The Pill May Decrease Bone Density 3Health News:Infinity Technology, Inc. Acquires Build My Own Site, Inc. 2
... 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 ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: