GlaxoSmithKline receives approvable letter for new indications for Arixtra (fondaparinux sodium) injection

Issued — Friday 2 February 2007, Philadelphia

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the once-daily anticoagulant, ARIXTRA (fondaparinux sodium) Injection, for the treatment of patients with:

  • Unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI)
  • ST-segment elevation myocardial infarction (STEMI)
    UA/NSTEMI and STEMI are types of acute coronary syndromes (ACS).

The FDA priority review was completed in six months. GSK will continue to work with the FDA to provide the additional information requested to complete the assessment of ARIXTRA for these indications. The company looks forward to making ARIXTRA available as an additional treatment option for the care of a broad range of patients with acute coronary syndromes. Results of the clinical studies (OASIS 5 and OASIS 6) supporting these two New Drug Applications have been presented and published in New England Journal of Medicine and JAMA, respectively.

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.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US 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 Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.

Enquiries:

UK Media enquiries:

Philip Thomson
Alice Hunt
Gwenan White

(020) 8047 5502
(020) 8047 5502
(020) 8047 5502

US Media enquiries:

Nancy Pekarek
Mary Anne Rhyne
Patricia Seif

(215) 751 7709
(919) 483 2839
(215) 751 7709

European Analyst/
Investor enquiries:

Anita Kidgell
David Mawdsley
Sally Ferguson

(020) 8047 5542
(020) 8047 5564
(020) 8047 5543

US Analyst/ Investor
enquiries:

Frank Murdolo
Tom Curry

(215) 751 5419

 

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.