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news.Wyeth Japan and Takeda Pharmaceutical's Enbrel has been approved by the Japan Ministry of Health, Labour and Welfare for the treatment of rheumatoid arthritis in patients who had an inadequate response to existing therapies.
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Following this affirmative Ministry of Health, Labour and Welfare (MHLW) decision, Enbrel (etanercept) will now be co-promoted by both Wyeth and Takeda Pharmaceutical in Japan.
“We are pleased with the approval decision and following pricing approval, we will make the product available to Japanese patients as soon as possible,” said Rune Bremberg, president of Wyeth Japan.
Enbrel is the only fully human, anti-TNF receptor approved to reduce the signs and symptoms of rheumatoid arthritis (RA) in patients who have demonstrated an inadequate response to traditional disease-modifying antirheumatic medicines.
The biological product can be used alone as a monotherapy and is administered twice weekly as a subcutaneous injection. Initially the product will be made available to medical institutions participating in an all-patient surveillance program.