Abbott Japan Co. and Eisai Co. announced that HUMIRA pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab) has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA)
Tokyo, Japan | January 20, 2010 | Abbott Japan Co., Ltd. (Pharmaceutical Products Group Headquarters: Tokyo, President: Gary M. Winer, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) today announced that HUMIRA® pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab) has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA). HUMIRA® is a fully human anti-TNF-alpha monoclonal antibody jointly developed by the two companies in Japan. This approval marks the second indication approved for HUMIRA® in Japan following rheumatoid arthritis, which was approved in April 2008. HUMIRA® will be the first biological agent approved for the treatment of psoriasis in Japan.
HUMIRA® is a fully human anti-TNF-alpha monoclonal antibody that exerts its effects by neutralising TNFalpha, a cytokine that plays a central role in inflammatory responses. While Abbott Japan is the marketing authorisation holder of HUMIRA® in Japan and Eisai is responsible for distributing the drug, the two companies have been co-promoting the drug. Post-marketing observation survey (PMOS) will be conducted in all patients treated with the drug over a given period of time in order to promote its effective and safe use in treating psoriasis.
In the clinical study conducted in 169 patients with moderate or severe PS in Japan, patients treated with HUMIRA® showed significant improvement in skin symptoms and QOL (quality of life) compared to those with placebo, indicating that the drug has a favourable tolerability profile.
Psoriasis is a chronic, non-communicable, inflammatory disease that is thought to involve interaction between inflammatory and skin cells. The number of patients with the disease in Japan is estimated to be approximately 100,000. Abbott Japan and Eisai will work in tandem to provide HUMIRA® as a new treatment for PS, which is considered to be the most common type of psoriasis, and PSA which is associated with progressive joint symptoms, thereby making contributions to improving the QOL of patients.
SOURCE: Eisai Co., Ltd.
Post Views: 115
Abbott Japan Co. and Eisai Co. announced that HUMIRA pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab) has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA)
Tokyo, Japan | January 20, 2010 | Abbott Japan Co., Ltd. (Pharmaceutical Products Group Headquarters: Tokyo, President: Gary M. Winer, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) today announced that HUMIRA® pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab) has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA). HUMIRA® is a fully human anti-TNF-alpha monoclonal antibody jointly developed by the two companies in Japan. This approval marks the second indication approved for HUMIRA® in Japan following rheumatoid arthritis, which was approved in April 2008. HUMIRA® will be the first biological agent approved for the treatment of psoriasis in Japan.
HUMIRA® is a fully human anti-TNF-alpha monoclonal antibody that exerts its effects by neutralising TNFalpha, a cytokine that plays a central role in inflammatory responses. While Abbott Japan is the marketing authorisation holder of HUMIRA® in Japan and Eisai is responsible for distributing the drug, the two companies have been co-promoting the drug. Post-marketing observation survey (PMOS) will be conducted in all patients treated with the drug over a given period of time in order to promote its effective and safe use in treating psoriasis.
In the clinical study conducted in 169 patients with moderate or severe PS in Japan, patients treated with HUMIRA® showed significant improvement in skin symptoms and QOL (quality of life) compared to those with placebo, indicating that the drug has a favourable tolerability profile.
Psoriasis is a chronic, non-communicable, inflammatory disease that is thought to involve interaction between inflammatory and skin cells. The number of patients with the disease in Japan is estimated to be approximately 100,000. Abbott Japan and Eisai will work in tandem to provide HUMIRA® as a new treatment for PS, which is considered to be the most common type of psoriasis, and PSA which is associated with progressive joint symptoms, thereby making contributions to improving the QOL of patients.
SOURCE: Eisai Co., Ltd.
Post Views: 115
