FDAnews
www.fdanews.com/articles/176054-pfizers-bococizumab-yields-positive-results-in-phase-3
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Pfizer’s Bococizumab Yields Positive Results in Phase 3

April 7, 2016

Pfizer’s bococizumab soared in a second Phase 3 study, meeting its co-primary endpoints of reducing low-density lipoprotein cholesterol at 12 weeks compared with placebo.

The SPIRE-AI study assessed the PCSK9 inhibitor in 299 patients with hyperlipidemia or mixed dyslipidemia receiving statin therapy.  SPIRE-AI is the second of six studies evaluating the candidate’s lipid-lowering capabilities.

Bococizumab is not approved in any country.