Arthritis

FDA Agrees to Review Cimzia(R) File for the Treatment of Rheumatoid Arthritis

Published in Lab Law Weekly, February 22nd, 2008

UCB announced that the U.S. Food and Drug Administration (FDA) agreed to accept, for filing and review, a biologics license application (BLA) for Cimzia(R) (certolizumab pegol) for the treatment of adult patients with active rheumatoid arthritis (RA). Cimzia(R) is an investigational agent. If approved, Cimzia(R) will be the first and only PEGylated anti-TNF (Tumor Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis.

"As a new anti-TNF, we believe that Cimzia(R) would provide an important new option for people living with this disease," said Olav Hellebo, President Inflammation Operations, UCB.

The BLA is based on...

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Source: Lab Law Weekly (2008-02-22)

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