Belgium-based biopharmaceutical company UCB has received FDA approval for Cimzia, the only PEGylated anti-tumour necrosis factor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
FDA approval was granted based on positive data from UCB’s comprehensive clinical programme, which included data from four multi-centre placebo-controlled Phase III trials, involving more than 2,300 patients with rheumatoid arthritis and over 4,000 patient-years experience.
CEO of UCB Roch Doliveux said that the approval was a major milestone for 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,” Doliveux said.
Cimzia was studied at dosing intervals of two or four weeks, and administered together with methotrexate or as a monotherapy.
A new prefilled Cimzia syringe is now also available for subcutaneous self-administration to US patients with moderate to severe Crohn’s disease and who have experienced 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.