June 1, 2021

Launch of UPLIZNAⓇ for I.V. Infusion 100mg
as a new option for the treatment ofNeuromyelitis Optica Spectrum Disorder in Japan
Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka; President &Representative Director; Hiroaki Ueno; hereafter, “MTPC”) today announced that
MTPC launched UPLIZNA Ⓡ for I.V. Infusion 100mg (generic name: inebilizumab(genetically modified), (UPLIZNA)) for the prevention of relapses of neuromyelitis
optica spectrum disorder (including neuromyelitis optica) on June 1, 2021 following
its NHI price listing on May 19, 2021. UPLIZNA is a humanized anti-CD19
monoclonal antibody and received manufacturing and marketing approval on March
23, 2021.
Neuromyelitis Optica Spectrum Disorder (NMOSD) is an autoimmune disease of
the central nervous system characterized by severe optic neuritis and transverse
myelitis, and relapse may occur repeatedly and a single relapse may lead to vision
loss or wheelchair activity.
UPLIZNA binds to a protein called CD19 which is expressed on B cells including
antibody-producing plasmablasts and plasma cells, and rapidly depletes these cells
from the circulation to prevent relapse in NMOSD. In global clinical study including
Japan in patients with NMOSD, the primary endpoint of relapse suppression effectwas confirmed by administration of UPLIZNA. In the U.S., it was approved for theindication of NMOSD on June 11, 2020 under the name of UPLIZNA.
UPLIZNA is a drug for the treatment of NMOSD with a new mechanism, and theconvenience of a dosing interval of once every six months enables treatment
tailored to the lifestyle of patients, and it can be provided as a new treatment
option for NMOSD patients in the relapse prevention period. In addition, formyasthenia gravis and IgG4-related disease as indications following NMOSD,
global phase 3 clinical studies including Japan are currently underway and will be
conducted in collaboration with Horizon Therapeutics plc.
MTPC will continue to actively pursue R&D in pharmaceuticals that address unmet
medical needs to provide “Creating hope for all facing illness.”.

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Mitsubishi Tanabe Pharma Corporation
Communication Crossroads Department
Media contacts: TEL:+81 6 6205 5119

Product Name

UPLIZNAⓇ for I.V. Infusion 100mg

JAN

Inebilizumab (genetically modified)

Indication

Prevention of relapses of NMOSD (including NMO)

Dosage

The usual adult dosage is 300 mg, and infusion at weeks 0and 2, followed by an intravenous infusion 6 months after thefirst dose, and then every 6 months thereafter.

Packaging

100 mg 10 ml (vial) x 3

NHI price

3,495,304 yen / 100 mg 10 ml (vial)

Approval (Japan)

March 23,2021

NHI price listing

May 19,2021

Release (Japan)

June 1,2021

Manufacturer

Mitsubishi Tanabe Pharma Corporation.

About Horizon Therapeutics plc
Horizon is focused on the discovery, development and commercialization ofmedicines that address critical needs for people impacted by rare, autoimmune andsevere inflammatory diseases. Our pipeline is purposeful: we apply scientificexpertise and courage to bring clinically meaningful therapies to patients. We
believe science and compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives, please visit
www.horizontherapeutics.com.
About Neuromyelitis Optica Spectrum Disorder (NMOSD)NMOSD is a rare, severe, relapsing, autoimmune disease of the central nervous
system that can be fatal. In Japan, it has a low prevalence rate of 2 to 4 cases per
100,000 population1. The body's immune system reacts against healthy cells (mostcommonly in the optic nerve, spinal cord and brain), resulting in NMOSD attack and2/3

severe damage. It may cause pain in the eye and vision loss, severe muscle
weakness and paralysis, numbness, loss of bladder and bowel control andrespiratory failure2. The disease is primarily associated with anti-aquaporin 4(AQP4) antibodies, which are detected in approximately 73%-90% of patients withNMOSD3.
1

Japanese Society of Neurology, 2017 guidelines for the diagnosis and treatment of multiple
sclerosis / neuromyelitis optica

2

National Institute of Neurological Disorders and Stroke, National Institutes of Healthhttps://www.ninds.nih.gov/Disorders/All-Disorders/Neuromyelitis-Optica-Information-Page

3

Chang VTW, Chang HM. Review: Recent advances in the understanding of thepathophysiology of neuromyelitis optica spectrum disorder. NAN. 2020; 46:199-218.

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