UCB has reported new clinical trial data that supports the safety of its anti-TNF therapy Cimzia when used by mothers who are breastfeeding their children.
Data has been reported from the CRADLE study, the first lactation trial designed to evaluate Cimzia concentrations in human mature breast milk and to estimate the average daily infant dose of the drug in maternal breast milk.
“UCB has reported data from a clinical trial revealing the low risk of mother treated with Cimzia experiencing a transfer of the drug from their bloodstream into their breast milk.“
Using a bioanalytical assay specifically designed for Cimzia, it was shown that there is minimal to no transfer of Cimzia into breast milk, with any crossover considered to be in the acceptable range for breastfeeding.
Given that disease onset for autoimmune conditions often coincides with women's peak reproductive years, this is an important finding, particularly given that only limited published data on the transfer of biologics into breast milk was previously available.
Emmanuel Caeymaex, head of immunology and executive vice-president at UCB, said: "We are committed to finding solutions to improve the lives of vulnerable, underserved patient populations. We are especially proud that this groundbreaking Cimzia research is helping to inform maternal and child healthcare for women living with immunologic diseases."
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