Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and.

Slides:

Advertisements

Similar presentations

1 Oxypurinol for Gout Arthritis Drugs Advisory Committee June 2, 2004 Cardiome Pharma Corp Vancouver, BC Canada.

Advertisements

Oncologic Drugs Advisory Committee

The Diabetic Retinopathy Clinical Research Network

AMD Trials and Treatments:

CR-1 ATACAND ® (candesartan cilexetil) Cardiovascular and Renal Drugs Advisory Committee Bethesda, Maryland July 18, 2002 C.

Assessment of Adalimumab Dose Selection for Adult Ulcerative Colitis Using Exposure-Response Analyses Michael Bewernitz1, Christine Garnett2,4, Klaus Gottlieb3,

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events Purpose To assess the relative efficacy of the antiplatelet drugs clopidogrel.

Hepatitis web study Hepatitis web study Peginterferon alfa-2a versus Interferon alfa-2a Phase 3 Treatment Naïve, Chronic HCV Zeuzem S, et al. N Engl J.

Cytomegalovirus DR.K.RAJA GHTM CHENNAI

Vitrasert Ganciclovir Intraocular Implant This is a reservoir style implant used for the delivery of the anti-viral drug ganciclovir to treat AIDs-related.

1 Tolvaptan for the Treatment of Hyponatremia Aliza Thompson, MD Medical Officer Cardiovascular and Renal Drugs Advisory Committee Meeting June 25, 2008.

Drug Treatment of Metastatic Breast Cancer

1 March 2003 ODAC: DOXIL ®, AIDS-KS ODAC Discussion on Accelerated Approval March 12-13, 2003 DOXIL ® (doxorubicin HCl liposome injection) Treatment of.

New Treatment Opportunity: Valganciclovir

1 March 2003 ODAC: DOXIL ®, Ovarian Cancer ODAC Discussion on Accelerated Approval March 12-13, 2003 DOXIL ® (doxorubicin HCl liposome injection) Treatment.

ODAC SCHERING-PLOUGH RESEARCH INSTITUTE 1 Temozolomide Oncology Drug Advisory Committee March 13, 2003 Craig L. Tendler, M.D. Vice President, Oncology.

1 FDA Review of NDA Valganciclovir for the Treatment of CMV Retinitis in AIDS Joseph Toerner, MD Medical Officer DAVDP.

1 One Year Post Exclusivity Adverse Event Review: Ofloxacin Ophthalmic Pediatric Advisory Committee Meeting September 15, 2004 Hari Cheryl Sachs, MD, FAAP.

1 NHLBI/NEI National Institutes of Health NHLBI/NEI National Institutes of Health.

Hormone Refractory Prostate Cancer A Regulatory Perspective of End Points to Measure Safety and Efficacy of Drugs Hormone Refractory Prostate Cancer Bhupinder.

Food and Drug Administration Division of Pulmonary and Allergy Drug Products Pulmonary-Allergy Drugs Advisory Committee Meeting July 13, 2005 Safety of.

Irbesartan Diabetic Nephropathy Trial (IDNT) Collaborative Study Group N Eng J Med 345: , 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of.

Impact of HSV-2 suppressive therapy with daily acyclovir on HIV-1 disease progression: a randomized placebo- controlled trial in Rakai, Uganda Steven J.

Pulmonary-Allergy Drugs Advisory Committee January 17, FLOVENT ® DISKUS ® NDA , S004 GlaxoSmithKline Pulmonary-Allergy Drugs Advisory Committee.

DRAFT SLIDES FOR NDA ADVISORY COMMITTEE PRESENATIONS.

Macugen (pegaptanib sodium injection) Dermatology and Ophthalmology Advisory Committee Meeting Rockville, Maryland August 27, 2004 Dermatology and Ophthalmology.

CMV (Cytomegalovirus) reactivation and immunosupression in allogeneic transplantation Marie Waller Bone Marrow Transplant Coordinator Manchester Royal.

1 SNDA Gemzar plus Carboplatin Treatment of Late Relapsing Ovarian Cancer.

Laser-Ranibizumab-Triamcinolone for DME Study DRCR.net Protocol I

Drug - Device Combination Issues : Oncology Perspective Ramzi Dagher, M.D. DODP/CDER/FDA.

1 orBec ® (oral beclomethasone dipropionate) NDA orBec ® (oral beclomethasone dipropionate) NDA DOR BioPharma, Inc. Oncologic Drugs Advisory.

Vitrasert Ganciclovir Intraocular Implant Reservoir style implant used for the delivery of the anti-viral prodrug ganciclovir. Vitrasert was the first.

Cardiovascular Risk and NSAIDs Arthritis Advisory Committee Meeting November 29, 2006 Sharon Hertz, M.D. Deputy Director Division of Analgesia, Anesthesia,

Clinical Trials – Human Gonadotropin Drug Products A Regulatory Perspective Shelley R. Slaughter, M.D., Ph. D. Reproductive Medical Officer Team Leader.

CR-1 Everolimus Benefit/Risk Assessment Howard J. Eisen, MD Thomas J. Vischer Professor of Medicine Chief, Division of Cardiology Drexel University College.

NDA SE-011 Docetaxel FDA Review. FDA Review Team Biostatistics –Clara Chu, PhD. –Gang Chen, PhD. Biopharmaceutics –Safaa Ibrahim PhD –Atiq Rahman,

Accelerated Approvals in Oncology

R DEVELOPMENT PROGRAM & STUDY RESULTS Slide # 31.

The Diabetic Retinopathy Clinical Research Network

The Research Question Clinical Effectiveness of Collaborative Care Management For Depression Over Time Garrison, GM; Angstman, KB; O’Connor S; Williams.

Zometa for Patients with Bone Metastases Overview and Review of Study 010 Grant Williams, M.D. Medical Team Leader Division of Oncology Drug Products.

R Slide # 1 VALGANCICLOVIR FOR THE TREATMENT OF CMV RETINITIS.

Scaling Up Retinal Screening in an HIV clinic in Nanning, China to prevent blindness from CMV retinitis Peter Saranchuk, MD TB-HIV Adviser Southern Africa.

1 Slides Shown at FDA Advisory Committee Eyetech Pharmaceuticals Pfizer, Inc. Dermatologic and Ophthalmic Drugs Advisory Committee Meeting 27 August 2004.

A Phase 3 Prospective, Randomized, International Study (MMY-3021) Comparing Subcutaneous and Intravenous Administration of Bortezomib in Patients with.

1 Presented at the March 13, 2003 Oncologic Drugs Advisory Committee meeting By Stephen Howell, M.D. Skyepharma, Inc.

SNDA Letrozole (Femara®) Indication: First-line therapy in post- menopausal women with advanced breast cancer. Prior approval: Second-line therapy.

Changes in Quality of Life and Disease- Related Symptoms in Patients with Polycythemia Vera Receiving Ruxolitinib or Best Available Therapy: RESPONSE Trial.

Agency Review of sNDA SE-006 DOXIL for Ovarian Cancer Division of Oncology Drug Products Office of Drug Evaluation 1 Center for Drug Evaluation.

Alemtuzumab BLA committee CD52 Expression Leukocytes B- lymphocytes T- lymphocytes Monocytes Macrophages Thymocytes Granulocytes (

REGULATORY HISTORY of ZOMETA and AREDIA JAW OSTEONECROSIS (ONJ) Oncologic Drug Advisory Committee March 4, 2005 Nancy S. Scher, M.D.

1 Daptomycin Safety Review Chuck Cooper, M.D. Medical Officer Division of Anti-Infective and Ophthalmology Products March 6, 2006 Advisory Committee Meeting.

1 Pharmacokinetic Information Submitted to Support Valganciclovir Use in Maintenance Therapy for CMV Retinitis Robert O. Kumi, Ph.D. Reviewer, Pharmacokinetics.

Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose Source: NDA Addendum. Note: P-value from treatment by dose interaction effect.

Zometa for Prostate Cancer Bone Metastases Protocol 039 Amna Ibrahim, M.D. Oncology Drug Products FDA.

Macugen (pegaptanib sodium injection) Advisory Committee Meeting August 27, 2004 Jennifer D. Harris, MD Medical Officer Division of Anti-Inflammatory,

Joint Non-Prescription Drugs and Pediatric Advisory Committee Meeting October 18-19, 2007 Considerations for Extrapolation of Efficacy from Adults to Children.

Date of download: 6/23/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Effect of Selumetinib vs Chemotherapy on Progression-Free.

1 Clinical Studies Section of Labeling Joseph Porres, M.D., Ph.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA.

Nymox Pivotal Phase 3 Fexapotide (NX-1207) BPH Extension Trial Successfully Meets Primary Endpoint

STAND Trial NC-006 (M-Pa-Z) Dr Suzanne Staples Principal Investigator at THINK 26 Mar 2015.

Posner-Schlossman Syndrome

Alcohol, Other Drugs, and Health: Current Evidence

Thrice-weekly maintenance therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) Josep Mallolas, Josep M. Gatell,

Cidofovir Treatment of Progressive Multifocal Leukoencephalopathy in a Patient Receiving Highly Active Antiretroviral Therapy Raymund R. Razonable, MD,

Thrice-weekly maintenance therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) Josep Mallolas, Josep M. Gatell,

Omalizumab is effective in cold urticaria—results of a randomized placebo-controlled trial Martin Metz, MD, Andrea Schütz, MD, Karsten Weller, MD, Marina.

Main inclusion criteria)

Monitoring plasma levels of ganciclovir in AIDS patients receiving oral ganciclovir as maintenance therapy for CMV retinitis C. Piketty, C. Bardin, J.

Switch to ATV/r monotherapy

Presentation transcript:

Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products HFD-550

Approved Products Cytovene-IV (ganciclovir) Foscavir Injection (foscarnet) Cytovene Capsules (ganciclovir) Vitrasert Implant (ganciclovir) Vistide Injection (cidofovir) Vitravene for Injection (fomvirsen)

Cytovene-IV (ganciclovir) Approved June 23, 1989 Clinical Data Source(s) for Approval –Study #1 - randomized, controlled trial, immediate versus delayed treatment (N = 42) –Study #2 - nonrandomized, retrospective, immediate versus delayed treatment (N = 41)

Cytovene-IV (ganciclovir) Primary Endpoints for Study #1 and #2: –Time to progression of CMV retinitis Primary Endpoint Analysis –Study #1 (photos): median time to progression of 50 days for immediate treatment; 14 days for delayed –Study #2 (exam): median time to progression of 71 days for immediate treatment; 29 days for delayed

Foscavir Injection (foscarnet) Approved September 27, 1991 Clinical Data Source(s) for Approval –randomized, open label, controlled trial, immediate versus delayed treatment (N = 24) Primary Endpoint –Time to progression of CMV retinitis

Foscavir Injection (foscarnet) Primary Endpoint Analysis –median time to progression of 93 days for immediate treatment; 22 days for delayed (photos)

Cytovene Capsules (ganciclovir) Approved December 22, 1994 Not approved for induction due to poor bioavailability (5% available) Study Design for Maintenance Indication –three randomized, open label trials with Cytovene-IV as comparator (N total = 505)

Vitrasert Implant (ganciclovir) Approved March 4, 1996 Clinical Data Source(s) for Approval –randomized, parallel, ganciclovir implant versus ganciclovir IV (N =188) Primary Endpoint –Time to progression of CMV retinitis

Vitrasert Implant (ganciclovir) Primary Endpoint Analysis –median time to progression of 210 days for immediate treatment; 120 days for delayed (photos)

Vistide Injection (cidofovir) Approved June 26, 1996 Clinical Data Source(s) for Approval –randomized, open label, controlled trial, immediate versus delayed treatment (N = 48) Primary Endpoint –Time to progression of CMV retinitis

Vistide Injection (cidofovir) Primary Endpoint Analysis –median time to progression of 120 days for immediate treatment; 22 days for delayed (photos)

Vitravene for Injection (fomvirsen) Approved August 26, 1998 Clinical Data Source(s) for Approval –limited, open label, controlled clinical studies, immediate versus delayed treatment (N = 80 eyes) Primary Endpoint –Time to progression of CMV retinitis

Vitravene for Injection (fomvirsen) Primary Endpoint Analysis –median time to progression of 80 days for immediate treatment; 14 days for delayed (photos)

Approved Products

Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products HFD-550

Valcyt 450 mg Tablets (valganciclovir hydrochloride) NDA

valganciclovir tablets NDA submitted September 28, 2000 Clinical Data Source(s) for Approval –randomized, open label, parallel group, valganciclovir versus ganciclovir IV (N=160) Primary Endpoint –proportion of patients with disease progression at week 4

valganciclovir tablets Primary Endpoint Analysis –7 subjects in valganciclovir arm and 7 subjects in the ganciclovir treatment arm had CMV progression at week 4 (photos)

valganciclovir tablets Analysis of CMV Retinitis Progression by Week 4 Compared to Baseline (Medical Officer’s Masked Photographic Assessment)

valganciclovir tablets