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Breaking News, Trials & Filings

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline’s sNDA for its anticoagulant product Arixtra Injection has been accepted for priority review by the FDA. This application was based on positive results from two Phase III trials (OASIS 5 and 6) that evaluated Arixtra in the treatment of a broad spectrum of patients with acute coronary syndromes (ACS).

The filing submission data included the OASIS 5 trial results, which compared Arixtra to Lovenox (enoxaparin) in patients with UA/NSTEMI, and OASIS 6, which compared Arixtra to standard therapies (unfractionated heparin or placebo) in STEMI patients.

“GSK is very encouraged by the FDA’s decision, based on these two ground- breaking trials with Arixtra in ACS,” said Dr. Lawson Macartney, senior vice president, Cardiovascular and Metabolic Medicine Development Centre, GSK. “This application supports our commitment to patients, physicians and the cardiovascular community. We look forward to building on our existing indications with Arixtra.”

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