The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of interferon beta therapies, including Biogen’s Plegridy and Avonex, during pregnancy and breastfeeding in relapsing multiple sclerosis (MS) patients.
The recommendation comes from data from the European Interferon Beta Pregnancy Registry and the national health registers of Finland and Sweden. The registries included safety data on exposure to interferon beta treatments in women of child-bearing age with MS.
According to data from over 1,000 pregnancy outcomes from registries and post-marketing studies, interferon beta exposure before conception or during the first trimester did not increase the risk of severe congenital anomalies.
As data collection took place during interferon beta contraindication use during pregnancy, the duration of exposure in the first trimester remains unclear. Therefore, treatment may have been interrupted when the pregnancy was detected or confirmed.
Furthermore, data regarding exposure in the second and third trimesters remains limited.
The company adds that existing data cannot validate the risk of spontaneous abortions with interferon beta exposure. However, data indicates no increase in risk to date.
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Biogen executive vice-president and chief medical officer Alfred Sandrock said: “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.
“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.”
Plegridy is a subcutaneous pegylated interferon for administration every two weeks for patients with relapsing MS, while Avonex is an interferon beta-1a formulation for relapsing forms of MS.