Mepolizumab Approved Naked monospecific

Antibody Information

Entry ID	143
INN	Mepolizumab
Status	Approved
Drug code(s)	SB-240563
Brand name	Nucala
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)	IL-5
Indications of clinical studies	Atopic dermatitis, Chronic obstructive pulmonary disease, Hypereosinophilic Syndrome, Asthma, Eosinophilic Oesophagitis, Eosinophilic Granulomatosis with Polyangiitis (aka Churg Strauss Syndrome), Nasal Polyps
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, Japan, China, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 02, 1996
Start of Phase 2	October 15, 1997
Start of Phase 3	October 15, 2003
Date BLA/NDA submitted to FDA	November 04, 2014
Year of first approval (global)	2015
Date of first US approval	November 04, 2015
INN, US product name	Mepolizumab
US or EU approved indications	Asthma, Eosinophilic granulomatosis with polyangiitis; treatment of pediatric patients with severe eosinophilic asthma between the ages of 6 to 11; FDA's approval in 2015 was for supplementary maintenance therapy for patients with severe asthma aged 12 years or older.

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	GlaxoSmithKline
Licensee/Partner	PDL
Comments about company or candidate	Approved in US Nov 4, 2015 and in the EU in early Dec 2015
Full address of company	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/