ROCKVILLE, Maryland—Cimzia^® (certolizumab pegol), the only pegylated anti-TNF, has been approved by the US Food and Drug Administration (FDA) for treatment of adults with moderately to severely active rheumatoid arthritis (RA). Cimzia offers flexible maintenance dosing. It can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered. It can be used with methotrexate or as monotherapy.

UCB, based in Brussels, Belgium, said that patients treated with Cimzia, together with methotrexate, experienced rapid and significant improvements in signs and symptoms, physical function, and pain as early as week one, and sustained at week 24 and for up to one year. Patients treated with Cimzia as a monotherapy experienced significant improvements in signs and symptoms, physical function, and pain.

The new drug is available in an exclusively designed, patient-friendly, prefilled syringe resulting from the UCB partnership with OXO^®. The new syringe carries the Arthritis Foundation Ease-of-Use Commendation.

"The approval of Cimzia for moderate to severe rheumatoid arthritis in the US is a major milestone for UCB, and most importantly, for people seeking a new treatment option to manage this debilitating condition," said Roch Doliveux, Chief Executive Officer of UCB. "UCB is committed to developing new therapies, such as Cimzia, to help meet the needs of patients living with rheumatoid arthritis and other immune diseases. I am also proud of our partnership with OXO and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis."

The new prefilled Cimzia syringe is now also available for subcutaneous self-administration to US patients with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy.