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FDA approves SPA for Anthera's short-term treatment for patients who experience acute coronary syndrome event
Monday, February 08 2010 | Comments
What's This?
Anthera Pharmaceuticals Inc. and the Food and Drug Administration agreed on a special protocol assessment regarding a Phase III trial for Anthera's lead product candidate, varespladib, which is also known as A-002.The study, dubbed VISTA-16, is expected to start by midyear and to be completed in 18 months.
Anthera is planning to enroll as many as 6,500 patients who will be randomized within 96 hours of experiencing an acute coronary syndrome event to receive once-daily varespladib or placebo for 16 weeks in addition to Pfizer Inc.'s Lipitor (atorvastatin calcium).
Six months after dosing has been completed, the trial investigators will obtain the patients' survival status. The primary endpoint of the trial will be to determine whether treatment with varespladib plus Lipitor is superior to placebo plus Lipitor in the time to the first occurrence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization as defined by recent FDA draft guidance.
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