UCB's Cimzia(R) Approved In The U.S. For Adult Patients Suffering From Moderate To Severe Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 May 2009 - 4:00 PDT

email to a friend   printer friendly   opinions  

Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the U.S. Food and Drug Administration (FDA) has approved Cimzia®, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia® (certolizumab pegol), is a PEGylated anti-TNFa (Tumor Necrosis Factor alpha). The product is currently being developed by UCB. Cimzia is one of several products which utilize Enzon's PEGylation technology, including PEG-INTRON®, Macugen®, and Pegasys®.

"Our PEGylation technology continues to enable very important therapeutics like Cimzia, benefiting patients with a wide variety of diseases," said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer.

About CIMZIA®

Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderate to severely active rheumatoid arthritis. Cimzia® was approved in Switzerland for induction of a clinical response and for the maintenance of a clinical response and remission in patients with active Crohn's disease who have not responded adequately to conventional treatment in September 2007. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.

Source
Enzon Pharmaceuticals, Inc.

• Additional
• References
• Citations