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FDA Ad-Comm Votes in Favor of WAYLIVRA(volanesorsen) for Treatment of Familial Chylomicronemia Syndrome

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Additional Relevant Details The Advisory Committee reviewed data from two Phase 3 clinical trials, APPROACH and COMPASS, as well as the ongoing APPROACH Open Label study for WAYLIVRA. Results from the phase 3 APPROACH trial, the largest study ever conducted in patients with FCS, show that patients with FCS treated with WAYLIVRA achieved a statistically significant mean reduction in triglycerides of 77% from baseline and decreased risk of pancreatitis.
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Catalyst Date
Occurred on:
May 10, 2018
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Related Keywords Waylivra, Familial Chylomicronemia Syndrome