Japan has approved manufacturing and marketing authorisation for the Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Auto Injector by Eisai Co., Ltd. and nippon medac Co., Ltd. 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.

Japanese Ministry of Health, Labour and Welfare (MHLW) have approved the additional formulation of 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). 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.

Japan has been using Methotrexate as the first-line option for the treatment of rheumatic arthritis. Eisai and nippon medac are delivering this treatment option to reduce the burden on patients with rheumatoid arthritis.