法瑞西单抗(Vabysmo)注射剂非临床审评（FDA）

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CENTER FOR DRUG EVALUATION AND

RESEARCH

APPLICATION NUMBER:

761235Orig1s000

NON-CLINICAL REVIEW(S)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

PHARMACOLOGY/TOXICOLOGY BLA REVIEW AND EVALUATION

Application number: 761235

Supporting document/s: 1

Applicant's letter date: 5-28-2021

CDER stamp date: 5-28-2021

Product: Vabysmo (faricimab)

Indication: Treatment of patients with neovascular (wet)

age-related macular degeneration (nAMD),

diabetic macular edema(DME),and diabetic

retinopathy(DR)

Applicant: Genentech,Inc

Review Division: Division of Ophthalmology

Reviewer: Maria I Rivera,PhD,DPT-RPURM/SM

Supervisor/Team Leader: Lori E Kotch,PhD,DABT,DPT-RPURM/SM

Division Director: Mukesh Summan,PhD,DPT-RPURM/SM

Project Manager: Wendy M.Streight,PhD

Template Version:September 1,2010

Disclaimer

Except as specifically identified,alldata and information discussed below and

necessary for approval of BLA 761235 are owned by Genentech or are data for which

Genentech has obtained a written right of reference.Any information or data necessary

for approval of BLA 761235 that Genentech does not own or have a written right to

reference constitutes one of the following:(1)published literature,or (2)a prior FDA

finding of safety or effectiveness for a listed drug,as reflected in the drug's approved

labeling.Any data or information described or referenced below from reviews or

publicly available summaries of a previously approved application is for descriptive

purposes only and is not relied upon for approval of BLA761235.

Reference ID:4897087

BLA #761235 Maria I. Rivera , PhD

TABLE OF CONTENTS

1 EXECUTIVE SUMMARY........................................................................................ 5

1.1 INTRODUCTION

.................................................................................................... 5

1.2 BRIEF DISCUSSIONOFNoNCLINICAL FINDINGS....................................................... 5

1.3 RECOMMENDATIONS............................................................................................ 5

2 DRUG INFORMATION............................................................................................ 9

2.1 DRUG...................................................................................................................9

2.2 RELEVANTINDs,NDAs,BLASANDDMF............................................................ 11

2.3 DRUGFORMULATION........................................................................................... 11

2.4 COMMENTSONNoVELExCIPIENTS.................................................................... 12

2.5 COMMENTSONIMPURITIES/DEGRADANTSOFCONCERN

....................................... 13

2.6 PROPOSEDCLINICALPoPULATIONANDDOSINGREGIMEN

................................... 13

2.7 REGULATORY BACKGROUND

............................................................................... 14

3 STUDIES SUBMITTED........................................................................................... 16

3.1 STUDIESREVIEWED............................................................................................ 16

3.2 STUDIESNoTREVIEWED.................................................................................... 17

3.3 PREVIOUSREVIEWSREFERENCED

.......................................................................17

4 PHARMACOLOGY................................................................................................ 17

4.1 PRIMARYPHARMACOLOGY

.................................................................................. 17

4.2 SECONDARYPHARMACOLOGY

............................................................................ 21

4.3 SAFETY PHARMACOLOGY

...................................................................................... 21

5 PHARMACOKINETICS/ADME/TOXICOKINETICS................................................21

5.1 PK/ADM.............................................................................................................21

5.2 ToxICOKINETICS................................................................................................. 24

6 GENERAL TOXICOLOGY........................................................................................ 24

6.1 SINGLE-DoSEToXICITY........................................................................................ 24

6.2 REPEAT-DOSEToXICITY.................................................................................... 25

7 GENETICTOXICOLOGY........................................................................................36

8 CARCINOGENICITY...............................................................................................36

9 REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY.................................. 38

9.1 FERTILITY ANDEARLYEMBRYONICDEVELOPMENT

............................................... 38

9.2 EMBRYONICFETAL DEVELOPMENT

...................................................................... 39

9.3 PRENATALANDPoSTNATALDEVELOPMENT

........................................................ 45

10 SPECIAL TOXICOLOGY STUDIES.................................................................... 46

11 INTEGRATED SUMMARY AND SAFETY EVALUATION................................ 47

Reference ID:4897087

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标签： #FDA #注射剂

摘要：

CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:761235Orig1s000NON-CLINICALREVIEW(S)DEPARTMENTOFHEALTHANDHUMANSERVICESPUBLICHEALTHSERVICEFOODANDDRUGADMINISTRATIONCENTERFORDRUGEVALUATIONANDRESEARCHPHARMACOLOGY/TOXICOLOGYBLAREVIEWANDEVALUATIONApplicationnumber:761235Supportingdocument/s:1Applicant...

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