Heart Drug Passes Priority Review
Feb. 6, 2007 — The FDA has issued an approval letter for GlaxoSmithKline’s once-a-day 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 agency’s priority review was completed in six months — going forward 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 says it 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.