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GSK announces changes to the REMS program for PROMACTA® (eltrombopag)

Issued: Tuesday 06 December 2011, Philadelphia, PA

GlaxoSmithKline [NYSE: GSK] today announced it has received approval from the U.S. Food and Drug Administration (FDA) to modify the REMS (Risk Evaluation and Mitigation Strategy) program for PROMACTA® (eltrombopag). 

PROMACTA is FDA approved for the treatment of the blood-platelet disorder thrombocytopenia, specifically in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. PROMACTA should not be used in an attempt to normalize platelet counts.

The FDA and GSK determined it was unlikely that collected safety data could distinguish between PROMACTA-related adverse events versus those related to the condition itself. Based on this and additional data submitted from clinical trials, the FDA and GSK concluded that the restrictive elements of the REMS could be eliminated.

Changes to the REMS for PROMACTA will include the elimination of the prescriber, patient and pharmacist enrollment requirements. Mandatory collection of safety data via completion and submission of program forms is no longer required. Healthcare providers are still encouraged to report adverse drug reactions to GSK to assist in the ongoing safety monitoring for PROMACTA requirement.

GlaxoSmithKline is implementing a comprehensive plan to inform healthcare providers and pharmacists of the changes to the REMS for PROMACTA and communicate the importance of understanding the serious risks of PROMACTA therapy and appropriate patient selection. Dispensing of PROMACTA will continue to be restricted to specialty pharmacies, hospital pharmacies and dispensing clinics.

The REMS for PROMACTA was implemented in November 2008. The REMS was designed to promote informed risk-benefit decisions and to evaluate the long-term safety of PROMACTA. Prescribers were required to complete and report baseline and periodic safety information for every patient receiving PROMACTA.

The modification of the REMS for PROMACTA does not reflect any changes to the safety profile of  PROMACTA. As stated in the Prescribing Information, including a Boxed Warning, treatment with  PROMACTA is associated with serious risks. 

Important Safety Information   

WARNING: Risk for Hepatotoxicity

PROMACTA may cause hepatotoxicity:

  • Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubinprior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
  • Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.
  • Discontinue PROMACTA if ALT levels increase to ³3X the upper limit of normal (ULN) and are:
    • progressive, or
    • persistent for ≥4 weeks, or
    • accompanied by increased direct bilirubin, or
    • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.


Please see full prescribing information, available at www.promacta.com, for additional important safety information.

About PROMACTA

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

Note to Editors

PROMACTA® is a registered trademark of the GlaxoSmithKline group of companies.

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 further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog (www.morethanmedicine.us.gsk.com/blog/).

 

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GlaxoSmithKline 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 2010.