European Medicine Agency Recommends Update to Label for Interferon Beta to Remove Pregnancy Contraindications

ßThe Committee for Medicinal Products for Human Use (CMPH), a subgroup of the European Medicines Agency (EMA), has recommended that contraindications to use during pregnancy and breastfeeding be removed from labels for ß interferons. This recommendation includes treatments for multiple sclerosis (MS), pegylated interferon ß-1A and interferon ß-1A (Plegridy and Avonex; Biogen, Cambridge, MA). 

The recommendation by the CMPH is supported by data from the European Interferon Beta Pregnancy Registry and national health registers in Finland and Sweden. Together this data provides the largest cohort study of safety data related to interferon ß exposure in women with MS of childbearing age. The data come from more than 1,000 pregnancies outside of clinical trials that indicate no increased risk of major congenital malformations (MCM) after maternal exposure to ß interferon at conception or during the first trimester compared with the general population. 

It should be noted, however, that the full duration of interferon ß treatment during the first trimester cannot be determined from this registry data. It is likely many of the mothers in the registry discontinued treatment upon verification of pregnancy because interferon ß treatment was contraindicated in pregnancy at that time. In addition, experience with exposure during the second and third trimesters remains highly limited. Although no harmful effects on breastfed children of women taking interferon ß are anticipated because early data suggests levels found in human milk are negligible, this too remains to be studied. 

“Women are diagnosed with MS at least 2 to 3 times more frequently than men, and the disease may strike during their child-bearing years. Choosing a treatment plan that allows women to continue or start their MS therapy while pregnant or breastfeeding is a step forward for those living with this chronic debilitating disease and their partners,” said Alfred Sandrock, Jr, MD, PhD, executive vice president and chief medical officer at Biogen. “This CHMP opinion gives physicians and their patients added confidence when considering treatment with Plegridy or Avonex, 2 important therapies for relapsing MS that have been prescribed to more than half a million people living with the disease.”