Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Reproductive Health Drugs

September 30, 2003

Hilton Hotel, the Ballrooms

620 Perry Parkway, Gaithersburg, MD

AGENDA

8:30 Call to Order and Opening Remarks Linda Giudice, M.D., Ph.D.

Introduction of Committee Chair

Conflict of Interest Statement Shalini Jain, PA-C, M.B.A. Executive Secretary, FDA

Opening Remarks Daniel Shames, M.D.

Director, Division of Reproductive and Urologic Drug Products (DRUDP)

FDA

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Issue: Discussion of NDA 21-322, Luveris® (lutropin alfa for injection), Serono, Inc., a recombinant human luteinizing hormone (r-hLH) drug product, proposed for concomitant administration with recombinant human follicle stimulating hormone

(r-hFSH), for the proposed indication of induction of ovulation in infertile women with severe luteinizing hormone and follicle stimulating hormone deficiency.

8:45 Clinical Presentation of James H. Liu, M.D.

Hypogonadotropic Hypogonadism Professor and Chair

in Women Dept. of Reproductive Biology

Case Western Reserve University

Cleveland, OH

9:30 Genetics of Hypogonadotropic Lawrence C. Layman, M.D.

Hypogonadism in Women Chief, Section of Reproductive

Endocrinology, Infertility and Genetics

Medical College of Georgia

Augusta, GA

10:30 Questions from the Committee

10:45 Break

11:00 SPONSOR PRESENTATIONS

SERONO, INC

Introduction & Regulatory History Pamela Williamson Joyce, RAC

Vice President

Regulatory Affairs & Quality Assurance-United States

Serono, Inc.

Need for and Role of LH: HH Women Jerome Strauss, M.D., Ph.D.

with Profound Gonadotropin Deficiency Luigi Mastroianni Jr. Professor

Director

Center for Research on Reproduction

and Women’s Health

University of Pennsylvania

Luveris® Clinical Development Program Paul Lammers, M.D.

Chief Medical Officer

Serono, Inc.

Clinical Perspective and Risk/Benefit Nanette F. Santoro, M.D.

Assessment Professor and Director

Division of Reproductive Endocrinology Department of Obstetrics &

Gynecology and Women’s Health

Albert Einstein College of Medicine

Summary and Conclusions Pamela Williamson Joyce, RAC

12:00 Questions from the Committee

12:15 Lunch

FDA PRESENTATIONS

1:00 Luveris®: The FDA perspective Shelley R. Slaughter, M.D., Ph.D.

Medical Officer Team Leader

Division of Reproductive

And Urologic Drug Products (DRUDP)

FDA

Kate Meaker, M.S.

Statistical Reviewer

Division of Biometrics II, FDA

1:45 Questions from the Committee

2:15 Open Public Hearing