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.
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