Eisai, nippon medac receive approval for Metoject subcutaneous injection pen (methotrexate) pen-type autoinjector in Japan
The drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin).
Japan: Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH have 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, and methotrexate is used as the first-line option for the treatment of rheumatic arthritis.
Methotrexate (MTX) is positioned as the anchor drug for rheumatoid arthritis treatment. 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.
nippon medac Co., Ltd. was established in April 2016 as the Japanese subsidiary of medac GmbH. It is working to develop new drugs that can expand treatment options for diseases for which therapeutic requirements have not yet been fully met.
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