UCB has announced that its anti-TNF therapy Cimzia has had a label change approved by the European Medicines Agency, allowing it to be used to treat women of childbearing age.
The approval makes Cimzia the first anti-TNF treatment for potential use in women with chronic rheumatic disease during both pregnancy and breastfeeding, helping them achieve optimal infant and maternal health, and reducing adverse pregnancy outcomes.
“UCB's anti-TNF therapy Cimzia has been approved in Europe for use in the treatment of women of childbearing age with chronic rheumatic disease.“
This decision was based on data from the landmark CRIB study, which showed that Cimzia users experience no or minimal placental transfer of the drug from mother to child during pregnancy.
Meanwhile, data from CRADLE - the prospective pharmacokinetic trial measuring the presence of an anti-TNF in breast milk - also found that minimal transfer of Cimzia was seen during lactation.
Emmanuel Caeymaex, head of immunology and executive vice-president for UCB's immunology patient value unit, said: "Today's label change for Cimzia is important for many European women who need treatment options to manage their chronic rheumatic disease without compromising their plans for pregnancy and breastfeeding."
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