BRIEF—EMA approves Cimzia label change

The European Medicines Agency has approved a label change for Cimzia (certolizumab pegol) from Belgian drugmaker UCB.

This decision makes it the first anti-TNF treatment option that could be considered for women with moderate to severe active rheumatoid arthritis, active psoriatic arthritis and ankylosing spondylitis, during both pregnancy and breastfeeding.

Emmanuel Caeymaex, UCB’s head of immunology and executive vice president, Immunology Patient Value Unit, said: “Today’s label change for Cimzia is important for many European women who need treatment options to manage their moderate to severe active rheumatoid arthritis, active psoriatic arthritis or ankylosing spondylitis without compromising their plans for pregnancy and breastfeeding”.

“UCB is executing on its patient value strategy to connect the unmet needs of patients with innovative science. The research we conducted to support this label change provides critical information for physicians and women as they plan for pregnancy and appropriate disease management. This new label underscores UCB’s commitment to delivering value to underserved patient populations and improving their overall treatment experience.”