Applications submitted to extend marketing authorisation for certolizumab pegol (Cimzia®) to include treatment of active psoriatic arthritis and active axial spondyloarthritis

Source: PR Newswire Area: News UCB has announced new regulatory filings with the European Medicines Agency (EMA) and the FDA to extend the marketing authorisation for certolizumab pegol (Cimzia®) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).   Certolizumab pegol is a Fc-free, PEGylated anti-TNF. In the EU, it is currently licensed in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. The submissions are based on data from the phase III placebo controlled RAPIDT-PsA study in 409 patients with adult onset active and progressive PsA, and the RAPIDT-axSpA study in 325 patients with active axSpA.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news