Wyeth K.K. and Takeda Pharmaceutical Company Limited (Takeda) have announced that Enbrel (etanercept) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies. As announced earlier, the product will be co-promoted by both Wyeth K.K. and Takeda.
Enbrel is the only fully human, anti-TNF receptor approved to reduce the signs and symptoms of RA in patients who had 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.
"We are pleased with the approval decision. We will make Enbrel available to Japanese patients as soon as possible," said Rune Bremberg, President and Representative Director of Wyeth K.K.
"Following this approval decision, we hope we will be able to support RA patients by providing Enbrel as new treatment option under the co-promotion with Wyeth K.K.," said Yasuchika Hasegawa, President & COO of Takeda.
http://www.takeda.co.jp and http://www.wyeth.jp