Navigation Links
FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
Date:3/3/2008

PHILADELPHIA and LONDON, March 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK; LSE) today announced that the United States Food and Drug Administration has granted Priority Review for PROMACTA(R) (eltrombopag) for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP). PROMACTA is an investigational, once-daily oral treatment that induces the production of cells in the bone marrow to generate platelets, which are critical in minimizing the incidence of bleeding in chronic ITP.

If approved, PROMACTA would be the first oral thrombopoeitin (TPO) receptor agonist for the short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce bleeding.

"Our goal for PROMACTA is to make available a targeted therapy in oral form for patients to help raise their platelet counts without having to suppress the immune system," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "The FDA designation of our submission for priority review is very encouraging and brings us closer to offering physicians and their patients PROMACTA."

The priority review designation means FDA is expected to make a decision on the NDA for the investigational compound within six months of the submission.

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

GSK also plans to submit a Marketing Authorization Application (MAA) for eltrombopag in the treatment of chronic ITP in Europe in 2008 where it will be marketed as REVOLADE(R). The compound is also being studied for long-term treatment of chronic ITP, as well as thrombocytopenia associated with Hepatitis C Virus cirrhosis and chemotherapy induced thrombocytopenia.

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.(1,2) There are estimated to be approximately 60,000 individuals diagnosed with chronic ITP in the U.S.(3) 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.(1)

About PROMACTA (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, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.

Note to Editors

PROMACTA(TM) is the proposed registered trademark of the GlaxoSmithKline group of companies to be used in the United States.

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

Enquiries:

US Media inquiries: Jeff McLaughlin 1 919 483 2839

Mary Anne Rhyne 1 919 483 2839

Nancy Pekarek 1 215 751 7709

UK Media enquiries: Philip Thomson (020) 8047 5502

Alice Hunt (020) 8047 5502

Joss Mathieson (020) 8047 5502

Gwenan White (020) 8047 5502

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

Tom Curry 1 215 751 5419

European Analyst/Investor

enquiries: David Mawdsley (020) 8047 5564

Sally Ferguson (020) 8047 5543

References:

(1)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.

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

(3)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 technology :

1. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
2. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
3. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
6. Chinese SFDA Grants Immtech Fast Track Status
7. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
8. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
9. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
10. Micromet Announces the Publication of BiTE Antibody Review in Drugs of the Future
11. FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/18/2017)... , May 18, 2017  Two Bayer U.S. ... Association (HBA) during its recent 28 th ... City.  The event showcases HBA,s longstanding mission of furthering ... of healthcare. Cindy Powell-Steffen , senior ... U.S. Radiology division, and Libby Howe , a ...
(Date:5/12/2017)... , May 12, 2017  The China and ... washing technology that consumes less water, energy and detergent, and features ... first product LaughingU, a shoebox-sized washing machine that washes and sanitizes ... ... Product, LaughingU, is compact, and does not require an external water ...
(Date:5/10/2017)... WASHINGTON , May 10, 2017  The ... doctors or employees of sleep therapy clinics to ... a sleep therapy clinic is involved in a ... as interested in hearing from an employee of ... involved in a kickback scheme to provide medical practice ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Accordant Technology, a trusted ... ExtraHop delivers an analytics-first approach, layered with machine learning, that provides real-time visibility ... to the cloud to the edge. Through the new partnership, customers get the ...
(Date:5/24/2017)... ... May 24, 2017 , ... Fiberstar, Inc., ... the food and beverage industry offers Citri-Fi®, a natural citrus fiber, to improve ... decision process. As a result, labels need to deliver simple, transparent and clear ...
(Date:5/23/2017)... ... 23, 2017 , ... Allegheny Health Network and the Alexis ... for Women’s Behavioral Health at West Penn Hospital , a unique facility that ... from pregnancy-related depression. Construction of the Center is underway with a scheduled opening ...
(Date:5/23/2017)... ... 23, 2017 , ... The National Council on Strength and ... the organization’s Certified Strength Coach credential has earned accreditation from the National Commission ... the competency of qualified candidates for jobs in the Strength and Conditioning profession. ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... equipment provider in the modern ART laboratory, to provide hands-on training utilizing cutting-edge ... Florida. , NextGen LifeLabs, a MedTech Group Purchasing vendor , will provide ...
Breaking Medicine News(10 mins):