Wyeth and Takeda have received approval from the Japanese Ministry of Health, Labour and Welfare, to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to Enbrel 25mg for SC Injection (etanercept). Enbrel is co-promoted by Wyeth and Takeda.
In addition, Wyeth has also received approval for the addition of Enbrel 10mg for SC Injection, a 10mg dose of the product.
Michael Goettler, President of Wyeth, said: “I am delighted that we will now also be able in Japan to provide Enbrel to JIA patients.”
“As demonstrated by the safety data gained from a post-marketing study of all 14,000 cases of use of Enbrel in adult RA in Japan, we will continue to work to maximize the added value of Enbrel, and will endeavor to offer patients and medical professionals in Japan the opportunity to have diverse options for treatment of related conditions,” he added.