GlaxoSmithKline announced that the US Food and Drug Administration 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 supporting these two New Drug Applications have been presented and published in New England Journal of Medicine and JAMA, respectively.