Japan – Metoject Subcutaneous Injection Syringe (Methotrexate) Launched In Japan For Rheumatoid Arthritis

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

nippon medac Co., Ltd.

Ueno

TEL: +81-(0)3-6661-6270

Copyright ©2022 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Japan – Eisai: Metoject Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis

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.

Copyright ©2022 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.