Navigation Links
GSK Update on FDA Review of Promacta(R) (Eltrombopag)
Date:6/20/2008

PHILADELPHIA, Pa. June 20 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration has extended the priority review period for PROMACTA(R) (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura, as they require more time to review the application. The Prescription Drug User Fee action date has been extended to September 19, 2008.

On May 30, the Oncology Drugs Advisory Committee unanimously voted, 16-0, that eltrombopag demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura, or ITP.

GSK will continue to work with the FDA towards the approval of eltrombopag in order to provide physicians and chronic ITP patients with a novel option for treating this difficult disease.

About Promacta(R) (Eltrombopag)

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, common cold, and nausea.

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.

US Media inquiries: Jeff McLaughlin 1 919 483 2839

Mary Anne Rhyne 1 919 483 2839

Nancy Pekarek 1 215 751 7709

UK Media inquiries: Claire Brough 44 20 8047 5502

Philip Thomson 44 20 8047 5502

Alice Hunt 44 20 8047 5502

Gwenan White 44 20 8047 5502

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

Tom Curry 1 215 751 5419

UK Analyst/Investor inquiries: David Mawdsley 44 20 8047 5564

Sally Ferguson 44 20 8047 5543

Gary Davies 44 20 8047 5503


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

Related medicine technology :

1. XTENT Announces European Regulatory Update
2. Sangamo BioSciences Provides Update on Diabetic Neuropathy Clinical Programs
3. Sunesis Pharmaceuticals Presents Updated Clinical Data From Ongoing Phase 2 Trial of Voreloxin (Formerly SNS-595) in Ovarian Cancer Patients at the 44th ASCO Annual Meeting
4. Genmab Announces Updates on Phase III Cancer Studies
5. Access Pharmaceuticals Presents Favorable Ovarian Cancer Data and Clinical Update on ProLindac(TM) Development at Prestigious International Symposium
6. Micromet to Present Clinical Update for BiTE Antibody MT103/MEDI-538 at the International Conference on Malignant Lymphomas
7. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
8. UPDATE: Infant Primates Given Vaccines on U.S. Childrens Immunization Schedule Develop Behavioral Symptoms of Autism
9. IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program
10. Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
11. Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , May 27, 2016 LabStyle ... Dario™ Diabetes Management Tool, today announced that the Company,s Chief ... Marcum MicroCap Conference being held June 1-2 in ... being held June 7-9 in Los Angeles, CA. ... discuss recent corporate and operational milestones, including the U.S. FDA ...
(Date:5/27/2016)... 2016 Hutchison China MediTech ... on the highly lucrative global oncology and immunology ... potential first-in-class or best-in-class tyrosine kinase inhibitor (TKI) ... strategic partners. HCM,s profitable Chinese healthcare business continues ... expect progress of the mid-to-late-stage pipeline during 2016-17 ...
(Date:5/27/2016)... Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), ... and Orphan Diseases, today announced that President & CEO Gerald ... SeeThru Equity MicroCap Conference   Where: ... , NY When: Tuesday, May 31 st , ... Where: Grand Hyatt Hotel, 109 East 42 nd St, ...
Breaking Medicine Technology:
(Date:5/31/2016)... ... May 31, 2016 , ... Spartan Bioscience today introduced the ... and convenience. , The Cube is exceptionally small—it takes up the space of ... easily into any space, whether in a hospital, doctor’s office, or pharmacy. , ...
(Date:5/31/2016)... , ... May 31, 2016 , ... WaterField Designs, an ... professionals, announces the waxed-canvas and leather Duo Dopp Kit , the ideal gift ... or ballistic nylon, the Duo is smartly designed for Dad’s grooming routine. ...
(Date:5/31/2016)... , ... May 31, 2016 , ... Phynd Technologies, Inc. ... GA; Houston Methodist – Houston, TX and Shore Medical Center – Somers Point, NJ. ... three different, leading EHR solutions, demonstrating the breadth of Phynd’s solution and its interoperability. ...
(Date:5/31/2016)... ... May 31, 2016 , ... Advertising Age has recognized ... provider, for the tenth consecutive year as a Top 20 Marketing Services Agency. ... SourceLink ranked eighteenth in the “U.S. CRM/Direct Marketing Agency” category. , Recent ...
(Date:5/30/2016)... ... May 30, 2016 , ... ... inside of FCPX," said Christina Austin - CEO of Pixel Film Studios. ... within Final Cut Pro X. Choose from abstract transitions to more simple wipes ...
Breaking Medicine News(10 mins):