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.
1
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
2
Reference ID:4897087
摘要：
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CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:761235Orig1s000NON-CLINICALREVIEW(S)DEPARTMENTOFHEALTHANDHUMANSERVICESPUBLICHEALTHSERVICEFOODANDDRUGADMINISTRATIONCENTERFORDRUGEVALUATIONANDRESEARCHPHARMACOLOGY/TOXICOLOGYBLAREVIEWANDEVALUATIONApplicationnumber:761235Supportingdocument/s:1Applicant...
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作者：冒牌货
分类：专业资料
价格：100质量币
属性：53 页
大小：667.53KB
格式：PDF
时间：2026-01-13
