UCB announced that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
Cimzia 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.
In clinical trials with Cimzia?, together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia?, together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001). "The approval of Cimzia? for moderate to severe rheumatoid arthritis in the U.S. 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 U.S. patients with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy. The FDA approval is based on UCB's comprehensive clinical program, including data from four multi-center placebo-controlled phase III trials, involving more than 2 300 patients with RA and over 4 000 patient-years experience. Cimzia? has been studied at dosing intervals of two or four weeks, and administered together with MTX or as monotherapy. Source: UCB, Belgium