TOKYO, Nov 16, 2022 – (JCN Newswire) – 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…