Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector “Metoject® Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL” (methotrexate). Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
This formulation incorporates the previously MHLW-approved Metoject Subcutaneous Injection pre-filled syringe formulation in a pen-type autoinjector and was developed to reduce the burden on patients and improve safety during self-injection. The drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin). The built-in needle cover prevents the needle from being seen prior to administration and automatically locks after administration to prevent accidental skin puncture.
It is estimated that there are approximately 700,000 – 800,000 rheumatoid arthritis patients in Japan,1 and methotrexate is used as the first-line option for the treatment of rheumatic arthritis. Eisai and nippon medac are committed to delivering this treatment option to reduce the burden on patients with rheumatoid arthritis, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.
About Metoject Subcutaneous Injection Pen (methotrexate)
Methotrexate (MTX) is positioned as the anchor drug for rheumatoid arthritis treatment.2 For rheumatoid arthritis, it is believed that MTX regulates cell growth by inhibiting folate metabolism in lymphocytes and other cells, and also has an anti-inflammatory mechanism through the promotion of adenosine synthesis in vascular endothelial cells and other cells in synovial membranes. Metoject Subcutaneous Injection Pen will be the first self-administrable MTX subcutaneous injection pen-type autoinjector for rheumatoid arthritis in Japan. It is approved in more than 16 countries in Europe.
About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as our human health care(hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook.
About nippon medac
nippon medac Co., Ltd. was established in April 2016 as the Japanese subsidiary of medac GmbH. We are working to develop new drugs that can expand treatment options for diseases for which therapeutic requirements have not yet been fully met. We will work diligently to deliver quality drugs as quickly as possible to improve the quality of life of patients and their families in areas with high medical need.
(1) Report from Study Committee on Rheumatoid Arthritis and Allergy www.mhlw.go.jp/stf/houdou/2r9852000001nfao-att/2r9852000001nfdx.pdf (2) Japan College of Rheumatology, Clinical practice guideline of methotrexate for patients with rheumatoid arthritis: 2016 updated version
Media Inquiries: Eisai Co., Ltd. Public Relations Department TEL：+81-(0)3-3817-5120
Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced today that they have launched the anti-rheumatic agent “Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL” (methotrexate, “MTX”) in Japan with the indication of rheumatoid arthritis. nippon medac obtained the manufacturing and marketing approval of Japan’s first self-administrable subcutaneous injection formulation of MTX, a first line option for the treatment of rheumatoid arthritis, on September 26, 2022. The product is published to Japan’s National Health Insurance Drug Price List, today.
The approval of Metoject in Japan is based on the results of a Phase III clinical trial (MC-MTX.17/RA) conducted in Japan by nippon medac to compare the efficacy and safety of Metoject with that of oral MTX, which consisted of a double-blind phase and an extension phase. Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
“Eisai has established a solid franchise and has extensive sales experience in the rheumatoid arthritis area in Japan. By adding Metoject to Eisai’s product lineup, we are now able to contribute to rheumatoid arthritis patients in a wide range of stages from the early stages of treatment,” said Terushige Iike, Senior Vice President of Eisai and President of Eisai Japan. “We are committed to making further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.”
“Metoject is the first drug for which nippon medac obtained its manufacturing and marketing approval in Japan. It is also the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan,” said Hirohisa Iriyama, Representative Director and President of nippon medac. “Although the drug is already widely used overseas, Eisai, which has extensive experience in this area, has been entrusted with the marketing of the drug in Japan, where there are an estimated 700,000 to 800,000 rheumatoid arthritis patients1, allowing us to bring the drug to them as a new treatment option. Nippon medac will continue to make further contributions in this area.”
For more information, visit www.eisai.com/news/2022/news202278.html.
Media Inquiries:
Eisai Co., Ltd. Public Relations Department TEL: +81-(0)3-3817-5120
Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced today that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare for the indication of the anti-rheumatic agent “Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL” (methotrexate, “MTX”) for the treatment of rheumatoid arthritis. Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan. Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
The approval is based on the results of a Phase III clinical trial (MC-MTX.17/RA) conducted in Japan by nippon medac to compare the efficacy and safety of Metoject with that of oral MTX, which consisted of a double-blind phase and an extension phase. In the double-blind phase of this trial, 102 rheumatoid arthritis patients who had not been treated with MTX received either 7.5 mg/week of Metoject or 8 mg/week of oral MTX for 12 weeks in repeated doses. The primary endpoint of ACR20 response* at 12 weeks was 59.6% in the Metoject group versus 51.0% in the oral MTX group, indicating comparable efficacy. The adverse drug reaction incidence rates in this trial were 25.0% in the Metoject group and 34.0% in the oral MTX group. In the double-blind phase, the most common adverse drug reactions (incidence 5% and higher) were stomatitis (5.8%) in the Metoject group, and nausea (12.0%) and stomatitis (6.0%) in the oral MTX group.
It is reported that there are approximately 700,000 – 800,000 rheumatoid arthritis patients in Japan. MTX is used as the first-line option for the treatment of rheumatic arthritis, but only the oral formulation is available in Japan. Eisai and nippon medac will provide a self-administrable subcutaneous injection as a new treatment option for rheumatoid arthritis patients in Japan as soon as possible, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.
*ACR20 is a criterion developed by the American College of Rheumatology that measures improvement in clinical symptoms of rheumatoid arthritis. It expresses the percentage of patients who demonstrated a 20% or greater improvement in tender and swollen joint counts and at least three of the following five disease activity variables: patient assessment of pain; patient assessment of global disease activity; physician assessment of global disease activity; patient assessment of physical function; and chronic response protein or erythrocyte sedimentation rate concentrations.
For more information, visit www.eisai.com/news/2022/news202269.html.
