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Print Edition StoriesThe U.S. Food and Drug Administration has given Lantheus Medical Imaging Inc. a Special Protocol Assessment (SPA) approval for a Phase 3 clinical trial of an injection agent for diagnosing coronary artery disease.
The SPA relates to the trial of flurpiridaz F-18, made as a Positron Emission Tomography (PET) imaging agent of myocardial perfusion in patients with possible coronary artery disease. It already has completed a Phase 2 trial and is set to begin the first of two Phase 3 trials this year. The SPA approval means the FDA has designated the trial ready to be evaluated for regulatory approval.
The planned Phase 3 trial is expected to test 1,350 patients with either known or suspected coronary artery disease at about 100 clinical trial sites. The goal of the trial is to evaluate the sensitivity and specificity of the imaging agent.
Last year, North Billerica-based Lantheus Medical Imaging acquired global rights to Ablavar, a blood pool imaging agent used in patients with peripheral vascular disease, a product that was formerly owned by bankrupt Epix Pharmaceuticals Inc. Prior to the July sale, Lantheus already held exclusive rights to Ablavar in the U.S., Canada and Australia.
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