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Repatha Reviewers

  • Analysis

Executive Summary

FDA staff involved in review of Amgen's PCSK9 inhibitor evolocumab for reducing LDL-cholesterol.

Repatha FDA Reviewers

Medical

Eileen Craig

Chemistry

Bazzarragchaa Damdinsuren (drug substance); Sang Bong Lee (drug product)

Clinical Pharmacology

Suryanarayana Sista; Justin Earp*; Nitin Mehrotra, Jaya Vaidyanathan

Microbiology

Michael Shanks (drug substance); Lakshmi Rani Narasimhan (drug product)

Pharmacology/Toxicology

C. Lee Elmore*

Statistics

Shuxian Sinks; Janelle Charles*

Cross-Discipline Team Leader

James Smith*

Regulatory Project Manager

Kati Johnson

*Reviewer worked on both Repatha and Praluent

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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