UCB gets FDA appro for Cimzia in RA

Belgium-based UCB has received approval for Cimzia (certolizumab pegol), the only PEGylated anti-tumor necrosis factor, from the US Food and Drug  Administration for the treatment of adult patients with  moderately-to-severely-active rheumatoid arthritis.

The FDA approval is based on a program including data from four  multicenter, placebo-controlled Phase III trials, involving more than  2,300 people 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 methotrexate or alone.

In clinical trials, Cimzia with methotrexate gave patients 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 methotrexate  alone.