Cardiome Oxyprim “Approvable” For Gout, But Product’s Future Now In Doubt
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests additional clinical and manufacturing data. Cardiome will “reflect” on FDA’s comments before making a final decision on oxypurinol.
You may also be interested in...
Cardiome Expects Anti-Arrhythmic NDA Submission By 2006
In a Phase III study, 52% of patients with recent onset atrial fibrillation converted to normal heart rhythm compared to 4% for placebo. RSD1235 could merit premium pricing over Wyeth’s Cordarone and amiodarone generics, Cardiome CEO says.
Cardiome Expects Anti-Arrhythmic NDA Submission By 2006
In a Phase III study, 52% of patients with recent onset atrial fibrillation converted to normal heart rhythm compared to 4% for placebo. RSD1235 could merit premium pricing over Wyeth’s Cordarone and amiodarone generics, Cardiome CEO says.
Cardiome Oxyprim, Chronic Gout Drug Trials May Use Surrogate Endpoints For Approval, Cmte. Says
Surrogate endpoint should seek a reduction in serum uric acid to a level of 6 mg/dL. Clinical outcome trials to confirm benefits of chronic gout products through reduction in gouty attacks should be carried out post-approval.