The FDA has approved Cimzia injection (certolizumab pegol, from UCB), a pegylated anti-tumor necrosis factor (TNF), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). This approval was based on UCB’s comprehensive clinical program, including data from four Phase III, multi-center, placebo-controlled studies, involving more than 2,300 patients with RA and over 4,000 patient-years experience. Cimzia was evaluated as monotherapy or in combination with methotrexate. Patients treated with Cimzia alone experienced significant improvements in signs and symptoms, as well as physical function and pain. Patients treated with Cimzia together with methotrexate experienced 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.
Cimzia will now also be available in a prefilled syringe, in addition to the single dose vials of lyophilized powder for subcutaneous injection after reconstitution, which is already on the market. Cimzia is already indicated in moderately to severely active Crohn’s disease to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy.
For more information call (800) 234-5535 or visit www.Cimzia.com.