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

Panel Votes, 16-0, in Favor of Short-Term Treatment of Chronic Idiopathic Thrombocytopenic Purpura (ITP)

CHICAGO, May 30 /PRNewswire-USNewswire/ -- GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration's Oncology Drugs Advisory Committee (ODAC) unanimously voted, 16-0, that PROMACTA(R) (eltrombopag) demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP). The FDA advisory committee was held onsite at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting.

The advisory committee reviewed studies evaluating the safety and efficacy of eltrombopag in the short-term setting. Clinical data were presented and discussed that support eltrombopag increased platelet counts and reduced bleeding.

"Chronic ITP is a condition, which can have serious complications and be life threatening. Two of the most fundamental endpoints are crucial to managing this disease -- improved platelet counts and decreased bleeding. If approved, this would make the drug a potential new clinical option that can address a true unmet medical need," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "An FDA approval for eltrombopag would represent an important development for these patients and would make the medication the first oral treatment of its kind for this disease. We look forward to working with the agency to achieve that goal."

In addition to today's recommendation, the FDA recently granted eltrombopag orphan drug designation for this indication. Orphan designation is a special status the FDA grants to products that treat a rare disease or condition, 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: LGND). It is being developed by GlaxoSmithKline. Eltrombopag is an investigational compound that has not received regulatory approval in any market for any indication at this time.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.

Note to Editors

PROMACTA(R) is a registered trademark of GlaxoSmithKline group of companies and is the proposed trade name in the United States.

To access the latest GSK news, visit http://us.gsk.com/

Inquiries:

US Media inquiries: Jeff McLaughlin 1 919 483 2839

Mary Anne Rhyne 1 919 483 2839

Nancy Pekarek 1 215 751 7709

US Analyst/Investor inquiries: Frank Murdolo 1 215 751 7002

Tom Curry 1 215 751 5419

References:

(1) US Food and Drug Administration. The Orphan Drug act (as amended). Accessed May 2008. http://www.fda.gov/orphan/oda.htm

(2) National Heart, Lung, and Blood Institute. Diseases and Conditions Index. http://www.nhlbi.nih.gov/health/dci/Diseases/Itp/ITP_WhatIs.html. Accessed November 12, 2007.

(3) Cines DB, Blanchette V. Idiopathic thrombocytopenic purpura. N Engl J Med. 2002;364: 995-1008.

(4) Feudjo-Tepie M, Robinson N, Bennett D. Prevalence estimates of adult chronic idiopathic thrombocytopenic purpura (ITP). J Thromb Haemost. 2008 doi: 10.1111/j.1538-7836.2008.02911.x.


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

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:8/16/2017)... ... August 16, 2017 , ... Any Lab Test Now® ... ranked #4429 on the newly released, 36th annual Inc. 5000 , the most ... at the most successful companies within the American economy’s most dynamic segment — its ...
(Date:8/16/2017)... ... August 16, 2017 , ... In 1987, ... celebrate 30 years in business this year, and they’re marking the milestone by ... to serve their patients. , It stands to reason that, given the ...
(Date:8/16/2017)... ... August 16, 2017 , ... QualDerm Partners ... novo development, today announced Cumberland Skin Surgery and Dermatology has joined ... with offices in both Hermitage and Lebanon, Tennessee, provides comprehensive general dermatology and ...
(Date:8/16/2017)... ... ... Maury Regional Health has announced a large-scale adoption of AccuVein vein visualization ... Regional Medical Center is making vein visualization part of their standard of care. , ... importantly, helps our staff members locate a vein that will provide good access to ...
(Date:8/16/2017)... ... August 16, 2017 , ... Paul Vitenas, MD, FACS , is honored ... The annual list identifies the nation’s top physicians, in a variety of specialties. This ... the top of Castle Connolly’s coveted ranking. , Castle Connolly is the nation’s trusted ...
Breaking Medicine News(10 mins):
(Date:7/31/2017)... , July 31, 2017 7D Surgical, developer ... Medical has purchased the 7D Surgical System to support its ... Washington D.C. and Virginia.  7D Surgical has ... for many of the premier medical facilities within those markets. ... ...
(Date:7/27/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported ... The Company reported second quarter net sales of $1.954 ... period, and an increase of 2.1% on a constant ... from the LDR Holding Corporation acquisition, second quarter 2017 ... or 0.3% on a constant currency basis. ...
(Date:7/26/2017)... , July 27, 2017  Radium Medical Aesthetics, a leading medical ... to delay aging by effectively addressing several skin conditions from the ... to become rougher and more fragile. The skin becomes more transparent ... exposure to the harmful UV rays from the sun contributes to ... ...
Breaking Medicine Technology: