GSK Arixtra Approved for New Use
February 2, 2007
GlaxoSmithKline has been issued an approvable letter from the FDA for the drug Arixtra for a new use in the treatment of patients with acute coronary syndromes.
Arixtra, an injectable drug, is now indicated for patients with unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI). UA/NSTEMI and STEMI are types of acute coronary syndromes.
Arixtra is currently used in patients undergoing certain types of surgery who are at risk for blood clots.
The FDA priority review was completed in six months. GSK said it will continue to work with the FDA to provide the additional information requested to complete the assessment of Arixtra for these indications.