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GlaxoSmithKline’s request for anticoagulant drug Arixtra to be approved in a new indication have been set back by an FDA request for more information.
The drug has only received an approvable letter from the agency for Arixtra (fondaparinux sodium) in the treatment of patients with acute coronary syndromes, including unstable angina and non-ST segment elevation myocardial infarction (STEMI) after a six-month priority review.
Data provided by GSK on this drug come principally from the OASIS 5 and OASIS 6 clinical trials and the latter, carried out in 12,000 patients with STEMI, found that Arixtra reduced death or recurrent heart attack by 14% and all-cause mortality by 13% compared with unfractionated heparin or placebo.
Arixtra, an oral factor Xa inhibitor, is already approved in the USA in the treatment of patients undergoing surgery who are at risk of deep vein thrombosis and pulmonary embolism.
