Navigation Links
PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA ADVISORY PANEL
Date:5/30/2008

n, affecting less than 200,000 individuals in the United States.(1)

Eltrombopag is an investigational, once-daily oral treatment developed to induce the production of cells in the bone marrow to increase platelets, which are critical in minimizing the incidence of bleeding in chronic ITP.

Eltrombopag, a novel oral thrombopoeitin (TPO) receptor agonist, if approved, would be the first oral short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce or prevent bleeding.

In the pivotal studies, the most common adverse events observed in patients taking eltrombopag were headache, nasopharyngitis, and nausea.

About the data

The NDA submission is supported by the largest database of clinical trial information on investigational therapies for chronic ITP patients. Two pivotal trials (one Phase III trial and one Phase II trial), were submitted to support the filing.

About ITP

Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.(2,3) There are estimated to be approximately 60,000 individuals diagnosed with chronic ITP in the U.S.(4) People with chronic ITP often bleed from small blood vessels causing bruises, nosebleeds or even fatal gastrointestinal or intra cerebral bleeds, although these are rare.(3)

About Eltrombopag

Eltrombopag is an oral, non-peptide thrombopoietin receptor agonist that has been shown in pre-clinical research and clinical trials to stimulate the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. Eltrombopag was discovered as a result of research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals (Nasdaq:

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. GlaxoSmithKline Files for FDA Approval of PROMACTA(TM) (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
2. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
3. DaVita Receives Civil Complaint
4. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
5. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
6. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
7. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
8. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
9. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
10. Prime Therapeutics Receives TIPPS Certification
11. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/6/2015)... ... ... With a new community program in the Livonia, Canton and Plymouth areas, ... new charity campaign to raise funds in support of the health and safety of ... Youth is a coalition created especially to educate and empower teens, bringing awareness to ...
(Date:7/6/2015)... Pompano Beach, Florida (PRWEB) , ... July 06, ... ... call center solutions, announced today that Randstad Technologies selected Aspect Software Unified IP ... provider in the United States, selected Aspect Unified IP as its future call ...
(Date:7/6/2015)... Texas (PRWEB) , ... July 06, 2015 , ... The ... thought-provoking look into the economic transformation associated with the U.S. economy over the past ... consequences associated with its use. In many ways, the book is a time capsule ...
(Date:7/5/2015)... ... July 05, 2015 , ... ... the Weed Master, a landscaping invention that effectively removes weeds without harming ... dollars," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "It ...
(Date:7/4/2015)... ... July 04, 2015 , ... ... published the results of an annual member survey , detailing the most ... More recently, the group broke that raw data down into charts detailing demographic ...
Breaking Medicine News(10 mins):Health News:Bowker Insurance Group and Nonprofit Livonia Save Our Youth Initiate New Charity Campaign in Livonia, MI to Provide for The Health and Safety of The Communities’ Youth 2Health News:Bowker Insurance Group and Nonprofit Livonia Save Our Youth Initiate New Charity Campaign in Livonia, MI to Provide for The Health and Safety of The Communities’ Youth 3Health News:Aspect Software Unified IP, Hosted by Promero, Selected by Randstad Technologies 2Health News:Aspect Software Unified IP, Hosted by Promero, Selected by Randstad Technologies 3Health News:New Book Brings Reveals The Repercussions Associated With The Global Economy 2Health News:8 Landscaping Tips That Can Save You Money Thanks To World Patent Marketing's Innovative Landscaping Invention 2Health News:8 Landscaping Tips That Can Save You Money Thanks To World Patent Marketing's Innovative Landscaping Invention 3Health News:8 Landscaping Tips That Can Save You Money Thanks To World Patent Marketing's Innovative Landscaping Invention 4Health News:8 Landscaping Tips That Can Save You Money Thanks To World Patent Marketing's Innovative Landscaping Invention 5Health News:The ‘South Atlantic’ Frequently Chooses Tummy Tuck for Plastic Surgery, Jacksonville, FL, Doctor Notes 2Health News:The ‘South Atlantic’ Frequently Chooses Tummy Tuck for Plastic Surgery, Jacksonville, FL, Doctor Notes 3
... cardiac function in aging mice, scientists report , MONDAY, ... age-related deterioration in the hearts of mice by suppressing ... system that helps regulate the life span of cells, ... the control of heart failure in humans. , "A ...
... of treatment, experts suggest , MONDAY, Oct. 12 ... estrogen/progestin hormone replacement therapy could signal increased chances ... , Women taking estrogen plus progestin who reported ... were 48 percent more likely to develop invasive ...
... ... additional New York counties - Washington, Warren, and Essex - to complement its growing service ... PPO plans, effective January 1, 2010. , ... Albany, N.Y. (Vocus) October 12, 2009 -- CDPHP announced the ...
... , OAKLAND, Calif., Oct. 12 Kaiser Permanente has ... Care Award" by the National Committee for Quality Assurance ... to provide health plan members with care that meets ... improve care for its culturally diverse members is a ...
... CARROLLTON, Ga., Oct. 12 , -- The Health ... a key step in the development of a national and ... industry , -- Americans seek care from more than 600,000 ... The majority of these physicians, however, cannot efficiently exchange patient ...
... SAN FRANCISCO, Oct. 7 Within3 , ... and life sciences institutions, today announced that the American College ... extend its Annual Scientific Meeting to a year-round forum by ... , ACG will launch the ACG GI ...
Cached Medicine News:Health News:A Gene Tweak Could Keep Heart Young 2Health News:A Gene Tweak Could Keep Heart Young 3Health News:With Hormone Therapy, Tender Breasts May Signal Cancer Risk 2Health News:With Hormone Therapy, Tender Breasts May Signal Cancer Risk 3Health News:CDPHP Medicare Choices Expands Service Area Northward 2Health News:CDPHP Medicare Choices Expands Service Area Northward 3Health News:Kaiser Permanente Recognized by National Committee for Quality Assurance for Innovative Efforts to Reduce Health Care Disparities 2Health News:Kaiser Permanente Recognized by National Committee for Quality Assurance for Innovative Efforts to Reduce Health Care Disparities 3Health News:Kaiser Permanente Recognized by National Committee for Quality Assurance for Innovative Efforts to Reduce Health Care Disparities 4Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 2Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 3Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 4Health News:Launch of First Year-Round Annual Scientific Medical Meeting Announced at Health 2.0 2
(Date:7/4/2015)... Spain , July 4, 2015 ... first-line chemotherapy for patients with unresectable metastatic colorectal ... Survival in that organ Patients with ... only to the liver experienced the greatest improvement ... the addition of SIR-Spheres Y-90 resin microspheres to ...
(Date:7/3/2015)... According to a new ... Management Market ECG, Implantable Loop Recorder, Manual Event ... Dual Chamber Pacemaker, CRT-D, CRT-P - Global Forecast ... Monitoring (CM) and Cardiac Rhythm Management (CRM) Devices ... 2020 from $21,137.7 Million in 2015, at a ...
(Date:7/3/2015)... Der Pharmariese Lupin ... eine 100-prozentige Beteiligung am Unternehmen ZAO "Biocom" ... Übernahme dringt Lupin in den russischen Pharmamarkt ... Mrd. RUB im Jahr 2014 zu den ... Health). Seit über einem Jahrzehnt verzeichnet der ...
Breaking Medicine Technology:New SIRFLOX Study Data Presented at World Congress of Gastrointestinal Cancer 2New SIRFLOX Study Data Presented at World Congress of Gastrointestinal Cancer 3New SIRFLOX Study Data Presented at World Congress of Gastrointestinal Cancer 4Cardiac Monitoring (CM) and Cardiac Rhythm Management (CRM) Devices Market Worth $26,646.5 Million by 2020 2Cardiac Monitoring (CM) and Cardiac Rhythm Management (CRM) Devices Market Worth $26,646.5 Million by 2020 3Cardiac Monitoring (CM) and Cardiac Rhythm Management (CRM) Devices Market Worth $26,646.5 Million by 2020 4Lupin übernimmt Biocom aus Russland 2Lupin übernimmt Biocom aus Russland 3
... July 16 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, ... Dr. Shizuko Sei et al. published the results of ... cell lung cancer (NSCLC). The paper, entitled "Synergistic Antitumor ... Cell Lung Cancer Cells" appears online in the July ...
... LEXINGTON, Massachusetts, July 16 Shire plc,(LSE: SHP, NASDAQ: ... received Fast Track designation from the U.S. Food and Drug,Administration ... the treatment of Type I Gaucher disease. Shire is working,with ... filing of its,NDA. , Fast Track ...
Cached Medicine Technology:Oncolytics Biotech(R) Inc. Announces Publication of Research on Synergistic Activity of Reovirus and Chemotherapy in NSCLC 2Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease 2Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease 3Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease 4
The proximally modular S-ROM Total Hip System provides custom capability at non-custom prices and is competitive with conventional porous coated systems....
The proximally modular S-ROM Total Hip System provides custom capability at non-custom prices and is competitive with conventional porous coated systems....
Quatroloc Revision Hip System...
A stable revision design with extensive sizes...
Medicine Products: