Navigation Links
Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union
Date:11/21/2008

THOUSAND OAKS, Calif., Nov. 21 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate(TM) (romiplostim) in the European Union (EU). The CHMP recommends Nplate for adult chronic immune (idiopathic) thrombocytopenia purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.

"Nplate will address an unmet medical need for thousands of patients in the European Union as it is a unique treatment option that increases platelet production and avoids immune suppression in adult chronic ITP patients," said Willard Dere, M.D., senior vice president and international chief medical officer at Amgen.

The novel peptibody technology upon which romiplostim is based represents a promising new approach for treating adult patients with chronic ITP, an autoimmune disorder affecting an estimated 50,000 people in the EU, which can lead to serious bleeding events that can be potentially life threatening.

Nplate, a thrombopoietin (TPO) mimetic, is a novel engineered therapeutic fusion protein with attributes of both peptides and antibodies, but is distinct from each. Nplate works similarly to TPO, a natural protein in the body. Nplate stimulates the TPO receptor, which is necessary for growth and maturation of bone marrow cells that produce platelets.

The CHMP positive opinion is based on data from two separate placebo-controlled Phase 3 studies, demonstrating that platelet counts were raised and sustained in 83 percent of patients for both splenectomised and non-splenectomised gro
'/>"/>

SOURCE Amgen
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. J. Craig Venter, Ph.D. Receives Double Helix Medal from Cold Spring Harbor Laboratory
2. Medarex Receives Milestone Payment for Investigational Antibody Targeting Integrin Receptors
3. Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
4. Life Recovery Systems Receives NIH Grant to Study Expanded Use of Its ThermoSuit System
5. Berlin Hearts EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval
6. Neuronascent, Inc. Receives Multiple Fundings for Its Neurogenesis Therapeutic Programs
7. TriReme Medical Inc. Receives CE Marking for Antares(TM) Coronary Stent System
8. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
9. AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA
10. Helix Receives Approval to Open Sites in Germany for its Ongoing Clinical Trial With Topical Interferon Alpha-2b in Patients With Ano-Genital Warts
11. Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... /PRNewswire-iReach/ -- June 28 th , 2014 – Oncolab, the ... AMAS cancer test, is making its AACC debut (booth #4051) ... which is a serum-based in vitro immunoassay, has been run ... tool in the fight against cancer recurrence. Photo ... 17 million cancer survivors in the US alone, the race ...
(Date:7/28/2014)... July 28, 2014  Air Products (NYSE: ... medical oxygen is vital to any healthcare facility. This ... not only improve the efficiency of its oxygen supply ... highlight these systems—including systems for emergency oxygen supply ... August 4-5 at the 51 st ASHE ...
(Date:7/28/2014)... , July 28, 2014 Research and ... Arthritis Drugs Market 2014-2018" report to their offering. ... a chronic disease that leads to inflammation and pain in ... and ankles. In addition, it causes inflammation of the tissues ... The symptoms of RA begin slowly, usually just ...
Breaking Medicine Technology:Oncolab, Inc. Exhibits Pioneering AMAS Cancer Test at AACC 2Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 2Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 3Global Rheumatoid Arthritis Drugs Market 2014-2018 2
(Date:7/28/2014)... (PRWEB) July 28, 2014 Ticket Down ... Colombia tickets in Miami, FL at the Sun Life ... South American football between Argentina and Brazil has is one ... stronger worldwide, more rivalries are forming on a consistent basis. ... reached a new height in the recent 2014 World Cup. ...
(Date:7/28/2014)... -- Endurance runners are far more likely to die ... to a new study. The researchers pointed ... climates are actually 10 times more likely to develop ... sudden death of a young and apparently healthy person ... heartbeat, often gets a lot more media attention. ...
(Date:7/28/2014)... Parker Waichman LLP, a personal injury law firm ... heroes of 9/11 are never forgotten, comments that the September ... According to a VCF message dated July 3, ... or before October 12, 2012 must file a Registration Form ... who were allegedly injured by the toxic dust cloud that ...
(Date:7/28/2014)... July 28, 2014 Bariatric Eating, a ... announced that it will be introducing three additional flavors ... this summer. The additional flavors include: , Inspire Summer ... protein , Inspire Pomegranate Razz Berry -­ Pomegranate, razz ... soft-serve vanilla cone , Bariatric Eating's Inspire protein ...
(Date:7/28/2014)... New York, New York (PRWEB) July 28, 2014 ... allege the long-acting birth control device caused some users ... its proper position in the uterus continue to mount ... to a new case list issued last month in ... allegations are pending in a multicounty litigation underway in ...
Breaking Medicine News(10 mins):Health News:Brazil vs. Colombia Tickets in Miami: Ticket Down Slashes Colombia vs. Brazil Tickets at Sun Life Stadium in Miami for Sept. 5th Showdown 2Health News:Brazil vs. Colombia Tickets in Miami: Ticket Down Slashes Colombia vs. Brazil Tickets at Sun Life Stadium in Miami for Sept. 5th Showdown 3Health News:Heat Stroke a Greater Threat to Endurance Runners Than Heart Problems: Study 2Health News:October 12, 2014 Deadline Approaching for 9/11 First Responders Suffering from Certain Cancers to Submit Their Registration to the VCF, Parker Waichman LLP Comments 2Health News:October 12, 2014 Deadline Approaching for 9/11 First Responders Suffering from Certain Cancers to Submit Their Registration to the VCF, Parker Waichman LLP Comments 3Health News:Bariatric Eating Announces Three New Protein Shake Flavors 2Health News:Mirena IUD Lawsuit Filings Exceed 920 in New Jersey Litigation, Bernstein Liebhard LLP Reports 2Health News:Mirena IUD Lawsuit Filings Exceed 920 in New Jersey Litigation, Bernstein Liebhard LLP Reports 3Health News:Mirena IUD Lawsuit Filings Exceed 920 in New Jersey Litigation, Bernstein Liebhard LLP Reports 4
... officers at 2009 annual meeting in Las Vegas, NV. , ... New ... MD, is the new President of the American Society for Aesthetic Plastic ... the leading national organization of board-certified plastic surgeons specializing in cosmetic surgery ...
... Medical Center, 2233 W. Division St., Chicago, through the ... $75,000 grant from the Chicagoland Affiliate of the Susan ... efforts for low-income women.This is the second year the ... 450 women who might not otherwise be able to ...
... answers and resources to help patients advocate for themselvesPHOENIX, ... for the Arizona Department of Insurance and others on ... developed to educate patients about the rights they have ... conference last Thursday on the Senate Lawn at the ...
... Because of similar symptoms, doctors urge overreaction if in doubt, ... a sharp, burning sensation in the chest, near the breastbone ... be a heart attack? , "It,s often difficult for people ... and associate clinical professor of medicine at the David Geffen ...
... May 5 Baptist Health South ... to be a key component of its continuing ... will use CareDiscovery Advance, a clinical performance benchmarking ... resource utilization. Built on the strength of healthcare ...
... fan coils, unit ventilators and indoor air handlersBURBANK, Calif., ... Handlers from Steril-Aire, Inc. may be used in a ... flu viruses, bacteria and mold. The easy-to-install kit ... unit ventilator systems and indoor air handlers with coils ...
Cached Medicine News:Health News:Salt Lake City Plastic Surgeon is New President of American Society for Aesthetic Plastic Surgery 2Health News:Salt Lake City Plastic Surgeon is New President of American Society for Aesthetic Plastic Surgery 3Health News:Salt Lake City Plastic Surgeon is New President of American Society for Aesthetic Plastic Surgery 4Health News:Susan G. Komen Funds Mammograms for Saints Mary and Elizabeth Medical Center 2Health News:Sen. Carolyn Allen Calls for Patient Rights and Treatment Option Awareness 2Health News:Telling Heartburn From Heart Attack Can Be Tricky 2Health News:Telling Heartburn From Heart Attack Can Be Tricky 3Health News:Baptist Health South Florida Selects Clinical Performance Benchmarking Solution From Thomson Reuters 2Health News:New UVC Kit Destroys Microorganisms Including flu Viruses, Bacteria and Mold 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
... 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: