Lanadelumab Approved Naked monospecific

Antibody Information

Entry ID	148
INN	Lanadelumab
Status	Approved
Drug code(s)	SHP643, DX-2930
Brand name	Takhzyro
mAb sequence source	mAb human
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	Phage display-derived

Therapeutic information

Target(s)	Plasma kallikrein
Indications of clinical studies	COVID-19, Hereditary angioedema attacks
Primary therapeutic area	Cardiovascular / hemostasis 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, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 15, 2013
Start of Phase 2
Start of Phase 3	November 15, 2015
Date BLA/NDA submitted to FDA	December 26, 2017
Year of first approval (global)	2018
Date of first US approval	August 23, 2018
INN, US product name	Lanadelumab, lanadelumab-flyo
US or EU approved indications	Types I and II hereditary angioedema in patients 12 years or older

Company information

Company	Shire
Licensee/Partner	None
Comments about company or candidate	Feb 23, 2018 press release: Biologics License Application (BLA) submitted to the U.S. FDA regarding SHP643 for the treatment of hereditary angioedema (HAE), and granted priority review. PDUFA date is August 26, 2018. Feb 2018: Shire announced Health Canada has accepted the company's request for priority review for the New Drug Submission (NDS) for lanadelumab (SHP643); the priority designation may be given up to 60 days before submission itself. Health Canada’s review of the NDS under Priority Review is expected to be completed in the second half of 2018. Feb 2018: Shire expects to start a Phase III pediatric trial with SHP643 for the treatment of HAE in the fourth quarter of 2018. May 2017: Phase 3 results for the HELP™ study, a global, multi-center, randomized, double-blind placebo-controlled parallel group trial that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in patients 12 years of age or older with Hereditary Angioedema (HAE) met primary endpoint. IND application for DX-2930 was filed in June 2013; Phase 1 studies NCT01923207 completed and NCT02093923 recruiting as of June 2014; good results reported in March 2015. DX-2930 is a human mAb inhibitor of plasma kallikrein for chronic prevention of hereditary angioedema attacks. EU and US orphan drug designations. Drug has Breakthrough therapy and Fast Track designations from the U.S. Food and Drug Administration for HAE.
Full address of company	300 Shire Way Lexington, MA 02421 USA North America United States of America https://sc8-cms-shire-com.shirecontent.com/contact-us

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None