Ocrelizumab Approved Naked monospecific

Antibody Information

Entry ID	127
INN	Ocrelizumab
Status	Approved
Drug code(s)	RG1594, PRO-70769, 2H7
Brand name	Ocrevus
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus, Lupus Nephritis
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Australia, UK, Switzerland
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2003
Start of Phase 2
Start of Phase 3	December 15, 2006
Date BLA/NDA submitted to FDA	April 28, 2016
Year of first approval (global)	2017
Date of first US approval	March 28, 2017
INN, US product name	Ocrelizumab
US or EU approved indications	Multiple sclerosis (relapsing and primary progressive forms of multiple sclerosis)

Description/comment

anti-CD20 Fv portion used in mosunetuzumab (?)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Genentech
Licensee/Partner	None
Comments about company or candidate	Approved March 28, 2017 in US; approved Sep 27, 2017 in EU; approved Sep 28 2017 in Switzerland Priority review; PDUFA date Dec 28, 2016. Breakthrough therapy designation for primary progressive MS. As of August 2013, focus is on MS studies
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us