• Subcutaneous injection for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in both adults and children
• Enspryng, the first approved drug applying Chugai’s proprietary recycling antibody technology, may provide convenience for people by subcutaneous injection every four weeks

TOKYO, August 26, 2020 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced the launch of Enspryng^® Subcutaneous Injection 120 mg Syringe [generic name: satralizumab (genetical recombination)] (hereafter, Enspryng) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD) [including neuromyelitis optica (NMO)]. Enspryng is the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody created by Chugai. In Japan, the product received manufacturing and marketing approval on June 29, 2020, and was listed on the National Health Insurance (NHI) reimbursement price list today.

“We are very pleased that Enspryng, which is the first approved drug applying our proprietary recycling antibody technology, is now available as a treatment for NMOSD with a novel mechanism of action in Japan,” said Chugai’s President and COO, Dr. Osamu Okuda. “As the first subcutaneous treatment for NMOSD administered every four weeks, we are confident that Enspryng will contribute to the treatment of a wide range of people from adults to children both in terms of relapse prevention and convenience.”

Enspryng, created by Chugai, is the pH-dependent binding humanized anti-IL-6 receptor antibody, which was the first product developed by applying our proprietary recycling antibody technology. The drug is believed to prevent relapse of NMOSD by inhibiting the cytokine IL-6 which is a key driver in NMOSD. In two global phase III clinical studies in NMO and NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline immunosuppressant treatment (NCT02028884) or as monotherapy (NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare disease. Enspryng has been approved in Japan, the U.S. Canada, and Switzerland. Enspryng is designated as an orphan drug in Europe. The application was accepted for review by the European Medicines Agency in 2019.

As a leading company in biopharmaceuticals, Chugai will continue to create pharmaceutical products that meet unmet medical needs through the development of innovative technologies and their application, contributing to healthcare and the health of people around the world.

Drug Information

Product name: Enspryng^® Subcutaneous Injection 120 mg Syringe

Nonproprietary name: Satralizumab (genetical recombination)

Indications:

Prevention of relapses of NMOSD (including NMO)

[Precautions concerning indications]

• Enspryng should be used in patients with NMOSD (including NMO)*
  *Should be referred to the “Guidelines for the Management of Multiple Sclerosis and Neuromyelitis Optica, 2017” (Japanese Society of Neurology) .
• The data showing efficacy for anti-AQP4 antibody-negative patients are limited. Enspryng should be administered to anti-AQP4 antibody-positive patients.

Dosage and administration:

The usual dosage for adults and children is a single dose of 120 mg satralizumab (genetical recombination) administered by subcutaneous injection at weeks 0, 2, and 4, and then once every 4 weeks thereafter.

 [Precautions concerning dosage and administration]

• If a scheduled dose is missed, administer ENSPRYNG as soon as possible and then according to the original dosing interval from that point onward.
• After a certain period of administration of satralizumab, the frequency of relapse should be investigated. If it is considered that the benefit of satralizumab is not expected (e.g. the frequency of relapse is not decreased), discontinuation of satralizumab administration should be considered.
• In pediatric patients, consideration should be given to the weight of the patient enrolled in the clinical study to determine whether the drug could be administered.

Date of approval: June 29, 2020

Date of NHI reimbursement price listing: August 26, 2020

Date of launch: August 26, 2020

Shelf life: 24 months

Drug price: Enspryng^® Subcutaneous Injection 120 mg Syringe, JPY 1,532,660/Syringe

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