The Committee for Medicinal Products for Human Use (CHMP) has recommended an update to marketing authorisations of approved interferon beta treatments – including Biogen’s Plegridy (peginterferon beta-1a) and Abonex (interferon beta-1a) – for use during pregnancy and breastfeeding.
This recommendation would remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS).
“Women are diagnosed with MS at least two to three times more frequently than men, and the disease may strike during their child-bearing years,” said Alfred Sandrock, Jr, Executive Vice President and Chief Medical Officer at Biogen.
He added: “This CHMP opinion gives physicians and their patients added confidence when considering treatment with Plegridy or Avonex, two important therapies for relapsing MS that have been prescribed to more than half a million people living with the disease.”
The CHMP opinion is based on data from the European Interferon Beta Pregnancy Registry, as well as the national health registers in Finland and Sweden, which together created the largest cohort studies providing safety data related to interferon beta exposure in women of child-bearing age with MS.
Data collected from more than 1,000 pregnancy outcomes from registries and post-marketing experience indicate no increased risk of major congenital anomalies following exposure to interferon beta before conception or during the first trimester of pregnancy.
However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment was likely interrupted when the pregnancy was detected and/or confirmed.
Additionally, experience with exposure in the second and third trimesters is very limited.
The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Limited data suggest the levels of interferon beta-1a excreted in human milk are negligible, and no harmful effects on the breastfed newborn/infant are anticipated.