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Transcript for the July 12, 2018 Meeting of the Antimicrobial Drugs

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Transcript for the July 12, 2018 Meeting of the Antimicrobial Drugs 1 1 FOOD AND DRUG ADMINISTRATION 2 CENTER FOR DRUG EVALUATION AND RESEARCH 3 4 5 6 ANTIMICROBIAL DRUGS ADVISORY COMMITTEE (AMDAC) 7 8 9 Thursday, July 12, 2018 10 8:00 a.m. to 3:35 p.m. 11 12 13 14 15 16 17 FDA White Oak Campus 18 Building 31, the Great Room 19 10903 New Hampshire Avenue 20 Silver Spring, Maryland 21 22 A Matter of Record (301) 890-4188 2 1 Meeting Roster 2 ACTING DESIGNATED FEDERAL OFFICER (Non-Voting) 3 Kalyani Bhatt, BS, MS 4 Division of Advisory Committee and Consultant 5 Management 6 Office of Executive Programs, CDER, FDA 7 8 ANTIMICROBIAL DRUGS ADVISORY COMMITTEE MEMBERS 9 (Voting) 10 Lindsey R. Baden, MD 11 (Chairperson) 12 Director of Clinical Research 13 Division of Infectious Diseases 14 Brigham and Women’s Hospital 15 Director, Infectious Disease Service 16 Dana-Farber Cancer Institute 17 Associate Professor, Harvard Medical School 18 Boston, Massachusetts 19 20 21 22 A Matter of Record (301) 890-4188 3 1 Dean A. Follmann, PhD 2 Assistant Director for Biostatistics 3 Chief Biostatistics Research Branch 4 National Institute of Allergy and Infectious Diseases 5 National Institutes of Health 6 Bethesda, Maryland 7 8 Michael Green, MD, MPH 9 Professor of Pediatrics, Surgery and Clinical & 10 Translational Science 11 University of Pittsburgh School of Medicine 12 Division of Infectious Diseases 13 Director, Antimicrobial Stewardship & Infection 14 Prevention 15 Co-Director, Transplant Infectious Diseases 16 Children’s Hospital of Pittsburgh 17 Pittsburgh, Pennsylvania 18 19 20 21 22 A Matter of Record (301) 890-4188 4 1 Barbara M. Gripshover, MD (via phone) 2 Associate Professor of Medicine 3 University Hospitals Cleveland Medical Center 4 Case Western Reserve University 5 Division of Infectious Diseases and HIV Medicine 6 Cleveland, Ohio 7 8 Vincent Lo Re, MD, MSCE 9 Associate Professor of Medicine and Epidemiology 10 Division of Infectious Diseases 11 Department of Medicine 12 Center for Clinical Epidemiology and Biostatistics 13 Perelman School of Medicine 14 University of Pennsylvania 15 Philadelphia, Pennsylvania 16 17 Ighovwerha Ofotokun, MD, MSc 18 Professor of Medicine 19 Division of Infectious Diseases 20 Department of Medicine 21 Emory University School of Medicine 22 Atlanta, Georgia A Matter of Record (301) 890-4188 5 1 Peter Weina, MD, PhD, FACP, FIDSA 2 Colonel, Medical Corps, USA 3 Chief, Department of Research Programs 4 Walter Reed National Military Medical Center 5 Division of Education, Training and Research 6 Bethesda, Maryland 7 8 TEMPORARY MEMBERS (Voting) 9 Warren B. Bilker, PhD 10 Professor of Biostatistics 11 Department of Biostatistics and Epidemiology 12 Perelman School of Medicine 13 University of Pennsylvania 14 Philadelphia, Pennsylvania 15 16 Josh A. Mailman, MBA 17 (Patient Representative) 18 Oakland, California 19 20 Thomas A. Moore, MD, FACP, FIDSA 21 ID Consultants, PA 22 Wichita, Kansas A Matter of Record (301) 890-4188 6 1 Michele J. Orza, ScD 2 (Acting Consumer Representative) 3 Chief of Staff 4 Patient-Centered Outcomes 5 Research Institute (PCORI) 6 Washington, District of Columbia 7 8 Kathrine R. Tan, MD MPH 9 Division of Parasitic Diseases and Malaria/ 10 Malaria Branch 11 Centers for Disease Control and Prevention 12 Atlanta, Georgia 13 14 Julie M. Zito, PhD 15 Professor of Pharmacy and Psychiatry 16 University of Maryland, Baltimore 17 Pharmaceutical Health Services Department 18 Baltimore, Maryland 19 20 21 22 A Matter of Record (301) 890-4188 7 1 ACTING INDUSTRY REPRESENTATIVE TO THE ANTIMICROBIAL 2 DRUGS ADVISORY COMMITTEE (Non-Voting) 3 Ercem S. Atillasoy, MD 4 (Acting Industry Representative) 5 Vice President, Global Regulatory Affairs and 6 Clinical Safety 7 Merck & Company, Inc. 8 North Wales, Pennsylvania 9 10 FDA PARTICIPANTS (Non-Voting) 11 Edward Cox, MD, MPH 12 Director 13 Office of Antimicrobial Products (OAP) 14 Office of New Drugs (OND), CDER, FDA 15 16 Sumathi Nambiar, MD, MPH 17 Director 18 Division of Anti-Infective Products (DAIP) 19 Office of Antimicrobial Products (OAP) 20 OND, CDER, FDA 21 22 A Matter of Record (301) 890-4188 8 1 Yuliya Yasinskaya, MD 2 Clinical Team Leader 3 DAIP, OAP, OND, CDER, FDA 4 5 Sheral Patel, MD 6 Medical Officer 7 DAIP, OAP, OND, CDER, FDA 8 9 Xianbin Li, PhD 10 Statistical Reviewer 11 Division of Biometrics IV (DBIV) 12 Office of Biostatistics (OB) 13 Office of Translational Sciences (OTS), CDER, FDA 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 9 1 C O N T E N T S 2 AGENDA ITEM PAGE 3 Call to Order and Introduction of Committee 4 Lindsey Baden, MD 11 5 Conflict of Interest Statement 6 Kalyani Bhatt, BS, MS 15 7 FDA Opening Remarks 8 Yuliya Yasinskaya, MD 19 9 Applicant Presentations – GlaxoSmithKline 10 Introduction 11 Joerg-Peter Kleim, PhD 27 12 Unmet Need 13 Kevin Baird, PhD 32 14 Study Design and Clinical Efficacy 15 Justin Green, MD 42 16 Safety Results 17 Alison Webster, MD 53 18 Clinical Perspective 19 Richard Price, MD 67 20 Clarifying Questions 76 21 22 A Matter of Record (301) 890-4188 10 1 C O N T E N T S 2 AGENDA ITEM PAGE 3 FDA Presentations 4 Presentation of Clinical Efficacy 5 Xianbin Li, PhD 119 6 Presentation of Clinical Safety 7 Elizabeth O'Shaughnessy, MB, BCh 130 8 Clarifying Questions 149 9 Open Public Hearing 203 10 Clarifying Questions (continued) 240 11 Questions to the Committee and Discussion 266 12 Adjournment 303 13 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 11 1 P R O C E E D I N G S 2 (8:00 a.m.) 3 Call to Order 4 Introduction of Committee 5 DR. BADEN: Good morning. I would first 6 like to remind everyone to please silence your cell 7 phones, smartphones, and any other devices that 8 make noise if you've not already done so. I would 9 also like to identify the FDA press contact, 10 Theresa Eisenman. If you are present, please 11 stand. She's in the back left. 12 I'm Dr. Lindsey Baden. I'm chairperson of 13 the Antimicrobial Drug Advisory Committee and I'll 14 be chai this meeting. I will now call this meeting 15 to order. We'll start by going around the table 16 and introduce ourselves. We'll start with the FDA 17 on the far left. 18 DR. COX: Good morning. Ed Cox, director of 19 the Office of Antimicrobial Products, CDER, FDA. 20 DR. NAMBIAR: Good morning. Sumathi 21 Nambiar, director, Division of Anti-Infective 22 Products, CDER, FDA. A Matter of Record (301) 890-4188 12 1 DR. YASINSKAYA: Good morning. Yuliya 2 Yasinskaya, medical team leader, Division of Anti- 3 Infective Products at the FDA. 4 DR. O'SHAUGHNESSY: Good morning. Elizabeth 5 O'Shaughnessy, medical officer, CDER, FDA. 6 DR. LI: Good morning. This is Xianbin Li, 7 a statistical reviewer from the FDA. 8 DR. FOLLMAN: Dean Follmann, head of 9 biostatistics at the National Institute of Allergy 10 and Infectious Diseases. 11 DR. BADEN: Please remember to turn on and 12 off your mics when you talk. Thank you. This is 13 for the record. 14 DR. HONEGGER: Jonathan Honegger, pediatric 15 infectious diseases, Ohio State University, 16 Nationwide Children's Hospital. 17 DR. CLARK: Nina Clark, infectious diseases, 18 Loyola University Medical Center, Maywood, 19 Illinois. 20 DR. GRIPSHOVER: Barb Gripshover. I'm in 21 adult infectious disease at Case Western Reserve 22 University, University Hospitals of Cleveland. A Matter of Record (301) 890-4188 13 1 MS. BHATT: Good morning. Kalyani Bhatt. 2 I'm with the Division advisory committee 3 consultant's management. I'm the acting DFO for 4 this meeting. 5 DR. BADEN: Lindsey Baden. I'm at Brigham 6 and Women's Hospital, Dana-Farber Cancer Institute, 7 and Harvard Medical School in Boston, adult 8 infectious diseases. 9 DR. WEINA: Peter Weina. I'm in infectious 10 diseases at the Walter Reed National Military 11 Medical Center. 12 DR. GREEN: Michael Green, University of 13 Pittsburgh, and Children's Hospital, Pittsburgh, 14 pediatric infectious diseases. 15 DR. ORZA: Michele Orza with the Patient- 16 Centered Outcomes Research Institute. I'm the 17 acting consumer representative today. 18 MR. MAILMAN: Josh Mailman. I'm a patient 19 advocate, a patient representative for today. 20 DR. MOORE: Dr. Tom Moore. I'm an 21 infectious disease physician at the University of 22 Kansas in Wichita. A Matter of Record (301) 890-4188 14 1 DR. BEYRER: Chris Beyrer, infectious 2 diseases, epidemiologist at the Johns Hopkins 3 Bloomberg School of Public Health in Baltimore. 4 DR. ZITO: Julie Zito, pharmacoepidemiology, 5 University of Maryland. 6 DR. KARTSONIS: Nick Kartsonis. I'm in 7 adult infectious disease. I help to lead clinical 8 research in infectious diseases and vaccines at 9 Merck and I serve as the industry rep on the 10 committee. 11 DR. BADEN: Thank you all for making the 12 time to join us today. For topics such as those 13 being discussed at today's meeting, there are often 14 a variety of opinions, some of which are quite 15 strongly held. 16 Our goal is that today's meeting will be a 17 fair and open forum for discussion of these issues 18 and that individuals can express their views 19 without interruption. Thus, as a gentle reminder, 20 individuals will be allowed to speak into the 21 record only if recognized by the Chairperson. We 22 look forward to a productive meeting.
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