Transcript for the April 23, 2018 Meeting of the Arthritis Advisory Committee

384 Pages·2017·1.08 MB·English

by  Janet Watkins

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1 FOOD AND DRUG ADMINISTRATION
2 CENTER FOR DRUG EVALUATION AND RESEARCH
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6 ARTHRITIS ADVISORY COMMITTEE
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10 Monday, April 23, 2018
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12 7:58 a.m. to 4:57 p.m.
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18 FDA White Oak Campus
19 Building 31, the Great Room
20 10903 New Hampshire Avenue
21 Silver Spring, Maryland
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A Matter of Record
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1 Meeting Roster
2 DESIGNATED FEDERAL OFFICER (Non-Voting)
3 Yinghua S. Wang, PharmD, MPH
4 Division of Advisory Committee and Consultant
5 Management
6 Office of Executive Programs, CDER, FDA
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8 ARTHRITIS ADVISORY COMMITTEE MEMBERS (Voting)
9 Jennifer Horonjeff, PhD
10 (Consumer Representative)
11 Founder and Patient Advocate
12 Savvy Cooperative
13 Patient Outcome and Quality Consultant
14 Division of Rheumatology
15 Department of Medicine
16 Columbia University Medical Center
17 Sunnyside, New York
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1 Alyce M. Oliver, MD, PhD
2 Professor of Medicine
3 Medical College of Georgia at Augusta University
4 Division of Rheumatology
5 Augusta, Georgia
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7 Jose U. Scher, MD
8 (Acting Chairperson)
9 Assistant Professor in Medicine and Rheumatology
10 New York University School of Medicine
11 New York, New York
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13 TEMPORARY MEMBERS (Voting)
14 Diane Aronson
15 (Patient Representative)
16 Naples, Florida
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1 Warren Bilker, PhD
2 Professor of Biostatistics
3 Department of Biostatistics, Epidemiology, and
4 Informatics
5 University of Pennsylvania Perelman School of
6 Medicine
7 Philadelphia, Pennsylvania
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9 Denise M. Boudreau, PhD, RPh
10 Professor (Affiliate)
11 Departments of Pharmacy and Epidemiology
12 University of Washington
13 Senior Scientific Investigator
14 Kaiser Permanente Health Research Institute
15 Kaiser Permanente Washington
16 Seattle, Washington
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1 Erica Brittain, PhD
2 Mathematical Statistician and Deputy Branch Chief
3 Biostatistics Research Branch
4 Division of Clinical Research
5 National Institute of Allergy and Infectious
6 Diseases
7 National Institutes of Health (NIH)
8 Bethesda, Maryland
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10 Liron Caplan, MD, PhD
11 Section Chief, Rheumatology
12 Denver Veterans Affairs Medical Center
13 Associate Professor of Medicine (Rheumatology)
14 University of Colorado – Denver
15 School of Medicine
16 Denver Colorado
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1 Beth L. Jonas, MD
2 Reeves Foundation Distinguished Professor of
3 Medicine
4 Interim Chief, Division of Rheumatology,
5 Allergy, and Immunology
6 Director, Rheumatology Fellowship Training Program
7 University of North Carolina School of Medicine
8 Chapel Hill, North Carolina
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10 James Katz, MD
11 Director
12 Rheumatology Fellowship and Training Branch
13 National Institute of Arthritis and Musculoskeletal
14 Diseases, NIH
15 Bethesda, Maryland
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1 Seoyoung Kim, MD, ScD, MSCE
2 Associate Professor of Medicine
3 Harvard Medical School
4 Associate Physician
5 Division of Pharmacoepidemiology &
6 Pharmacoeconomics
7 Division of Rheumatology, Immunology & Allergy
8 Brigham and Women’s Hospital
9 Boston, Massachusetts
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11 Donald R. Miller, PharmD
12 Professor of Pharmacy Practice
13 College of Health Professions
14 North Dakota State University
15 Fargo, North Dakota
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17 Thomas Ortel, MD, PhD
18 Chief, Division of Hematology
19 Duke University Medical Center
20 Durham, North Carolina
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1 I. Jon Russell, MD, PhD, ACR Master
2 Medical Director
3 Fibromyalgia Research and Consulting
4 Arthritis and Osteoporosis Center of South Texas
5 San Antonio, Texas
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7 Soko Setoguchi, MD, DrPH
8 Associate Professor of Medicine and Epidemiology
9 Rutgers Robert Wood Johnson Medical School
10 New Brunswick, New Jersey
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12 ACTING INDUSTRY REPRESENTATIVE TO THE COMMITTEE
13 (Non-Voting)
14 Sean Curtis, MD
15 (Acting Industry Representative)
16 Head, Global Scientific Affairs
17 Merck Research Laboratories
18 Merck and Co, Inc.
19 Rahway, New Jersey
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1 FDA PARTICIPANTS (Non-Voting)
2 Mary T. Thanh Hai, MD
3 Deputy Director
4 Office of Drug Evaluation II (ODE-II)
5 Office of New Drugs (OND), CDER, FDA
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7 Sally Seymour, MD
8 Deputy Director for Safety
9 Division of Pulmonary, Allergy, and Rheumatology
10 Products (DPARP)
11 ODE-II, OND, CDER, FDA
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13 Nikolay Nikolov, MD
14 Clinical Team Leader
15 DPARP, ODE-II, OND, CDER, FDA
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17 Raj Nair, MD
18 Clinical Reviewer
19 DPARP, ODE-II, OND, CDER, FDA
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1 C O N T E N T S
2 AGENDA ITEM PAGE
3 Call to Order and Introduction of Committee
4 Jose Scher, MD 13
5 Conflict of Interest Statement
6 Yinghua Wang, PharmD, MPH 17
7 FDA Opening Remarks
8 Nikolay Nikolov, MD 21
9 Applicant Presentations – Eli Lilly
10 Introduction
11 Robin Wojcieszek, RPh 36
12 Unmet Need for Patients with
13 Rheumatoid Arthritis
14 Mark Genovese, MD 43
15 Clinical Design and Efficacy of
16 Baricitinib
17 Terence Rooney, MD 49
18 Safety of Baricitinib
19 Melissa Veenhuizen, DVM, MS 70
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