Belgium-based biopharmaceutical company UCB has received FDA approval for Cimzia, the only PEGylated anti-tumor necrosis factor, for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
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 rheumatoid arthritis (RA) and over 4,000 patient-years experience. Cimzia has been studied at dosing intervals of two or four weeks, and administered together with methotrexate or as monotherapy.
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.
Cimzia can be dosed at 400mg initially and at weeks two and four, followed by 200mg every other week; for maintenance dosing, 400mg every four weeks can be considered, the company said.
Roch Doliveux, CEO of UCB, said: 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. UCB is committed to developing new therapies, such as Cimzia, to help meet the needs of patients living with RA and other immune diseases.