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 w
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:7/10/2014)... , July 10, 2014  The U.S. Department ... three-year grant to University Hospitals (UH) Case Medical Center ... new national model aimed at improving care for patients ... Care," the project will test a unique model developed ... with late-stage disease, significant comorbidities, or demonstrated need for ...
(Date:7/10/2014)... , July 10, 2014 Yesterday, former ... (Moberg) medical device manufacturing facility. Rep. Kennedy and ... neurological monitors facilitate cutting-edge research in neurological disease ... and mental health advocate, Garen Staglin , ... to fostering fundamental changes that will radically accelerate ...
(Date:7/10/2014)... , July 10, 2014  Decision Resources ... surveyed infectious disease (ID) specialists are willing to ... Orbactiv (oritavancin) for use as OPAT, approximately two-thirds ... these agents to their hospital inpatients. However, our ... OPAT patients are initiated on OPAT following hospital ...
Breaking Medicine Technology:University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 2University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 3University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 4Representative Patrick Kennedy visits Moberg's medical device facility to discuss improvement in brain injury care 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3
... Terumo Heart, Inc. announced,today that they have ... Drug,Administration (FDA) to begin enrollment in the ... for a Bridge-to-Transplant (BTT) indication., (Logo: ... http://www.newscom.com/cgi-bin/prnh/20080303/CLM012 ), Dr. David Munjal, ...
... 29 Eisai Corporation of,North America, a wholly-owned ... the Food and Drug Administration (FDA) has accepted ... short-term (up to,eight weeks) treatment of gastroesophageal reflux ... indicated that the sNDA will receive,priority review in ...
Cached Medicine Technology:DuraHeart(TM) LVAS Receives Conditional Approval for US Pivotal Trial 2FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents 2
(Date:7/12/2014)... July 12, 2014 Dubai is buzzing ... legend is heading to the UAE. The National ... will be in the UAE from 28-31 October to ... support of diabetes awareness. The event is being organized ... and event management company based in Dubai. The announcement ...
(Date:7/12/2014)... Praeclarus Press is excited to offer ... resource for women in need of lactation support. Statistics ... from their children. Today’s mothers receive very clear messages ... often feel unsupported when it comes to balancing working ... insights, and written by Nancy Mohrbacher, an international breastfeeding ...
(Date:7/12/2014)... 12, 2014 Restore My Vision Today ... Samantha Pearson, a couple boasting very impressive credentials on ... My Vision Today as a way to help consumers ... become in their respective patients’ treatments . ... a “secret” trove of pertinent information relevant to eye ...
(Date:7/12/2014)... Palm Beach, FL (PRWEB) July 12, 2014 ... variety of high-quality peptides that are used solely in ... To honor two successful years in business, Maxim Peptide, ... LLC, has just launched a new and updated website ... the research blog section has been updated with fascinating ...
(Date:7/12/2014)... Ladies, it doesn't matter what your budget is, the trendy ... an affordable gown can visit Discount-Dress.com (a reliable ... dream items. Recently, the company has announced its new selection ... that, it is also providing great discounts for these unique ... of this promotion is July 29, 2014. , Discount-Dress.com ...
Breaking Medicine News(10 mins):Health News:Los Angeles Basketball Legend Headed to Dubai 2Health News:Los Angeles Basketball Legend Headed to Dubai 3Health News:Praeclarus Press Announces the Release of Working and Breastfeeding Made Simple by Nancy Mohrbacher, A Much Needed Resource For Today's Working Mothers 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 3Health News:Maxim Peptide Celebrates Second Anniversary Online with an Updated Website and Special Deals Section 2Health News:Worldwide Brides-to-be: It Is Time To Show Your Beauty By Wearing A Trendy Summer Short Wedding Dress From Discount-Dress.com 2
... (PHILADELPHIA) An immune system messenger molecule that normally helps ... multiple sclerosis (MS). Neurology researchers led by Abdolmohamad ... Department of Neurology at Jefferson Medical College of ... Neuroscience in Philadelphia, have found that the protein ...
... New research provides clues about the causes of lupus ... to Nilamadham Mishra, M.D., from Wake Forest University Baptist ... College of Rheumatology in Boston. , The studies looked ... accelerated cell death that seems to be behind many ...
... at NOCC Annual Conference in Houston, TX November ... the National Ovarian Cancer,Coalition, Inc. (NOCC) Board of ... regional offices to better support its network of,80 ... administrative and management,responsibilities will be transitioning to an ...
... leading EMR now offers rapid start-ups, without forcing doctors into ... ... Calif., Nov. 9 Infor-Med Corporation,today announced the pre-release of Praxis ... The dynamic,tool allows physicians to tap into the knowledge of other ...
... YORK, Nov. 9 Many Americans are currently ... health benefits. But they still feel,aches and pains ... can affect which pain,relievers they can use. ... Registered journalists can access video, audio, ...
... Council on,Disability (NCD) today invited the Boston disability community ... take place at,the Hyatt Regency Boston, One Avenue de ... a.m. until 5:00 p.m.; Friday,November 30 from 8:30 a.m. ... until 11:15 a.m., Public comment sessions will be ...
Cached Medicine News:Health News:Jefferson neuroscientists show anti-inflammation molecule helps fight MS-like disease 2Health News:Research suggests targeted treatment strategies for lupus 2Health News:Infor-Med, Inc. Announces New Praxis EMR Version 4 with The Praxis Knowledge Exchanger(R) 2
Inquire...
Inquire...
The Optima III 45 cm line of laparoscopic hand instruments is ideal for operative laparoscopic/endoscopic procedures or when a longer instrument is needed....
The Optima III line of laparoscopic hand instruments provides a well-crafted set of instruments designed for strength and durability....
Medicine Products: