Cimizia承認

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years 2008.10
the only PEGylated anti-TNF (Tumor Necrosis Factor) - presented at the American College of Rheumatology (ACR) Annual Scientific Meeting. Results from the open-label extension study to RAPID 1 met both co-primary endpoints (American College of Rheumatology (ACR) 20 response(a) scores at Week 24 and change from baseline in modified Total Sharp Scores at Week 52). Results also showed that CIMZIA together with methotrexate (MTX) provided ACR 20 response as early as Week 1 with sustained long-term benefit in relieving symptoms of rheumatoid arthritis (RA) through 100 weeks.


Biotechnology Japan：Webmasterの憂鬱
[抗体医薬は第2世代に、ヒトES細胞規制緩和に落とし穴]

UCB社　Cimizia　(PEG化低分子抗体・anti-TNFa・大腸菌生産） certolizumab pegol
FabのPEG化。
低分子化の狙いはpo可能（将来的に）、コスト安、組織浸潤性、でよいのかな。

FabにするとIgGでは露出していなかった残基が露出しそうだけれど、抗原性は大丈夫なのかな？

PEG化技術はNEKTARより。
http://www.nektar.com/wt/page/cimizia

References
抗体医薬第2世代の幕開け、FDA、大腸菌で生産した組換え抗体「Cimizia」を承認抗体医薬のコストとQOLの壁打破へ 2008.4
Cimzia Launch: Nothing Simple About It 2008.5
UCB GETS POSITIVE RESULTS FROM TWO CIMIZIA PHASE III STUDIES.　2007.2