CHMP Supports Interferon-β During Pregnancy, Breastfeeding in MS

Megan Brooks

September 23, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion to recommend updating the label of approved interferon-β products to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS), according to manufacturers Biogen and Merck.

Biogen makes peginterferon-β-1a (Plegridy) and interferon-β-1a (Avonex), and Merck makes the interferon beta-1a product Rebif.

According to both Merck and Biogen, a large body of data on pregnancy outcomes from registries and post-marketing experience show no increased risk of major congenital anomalies following exposure to interferon-β 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-β use was contraindicated during pregnancy, and treatment was likely interrupted when the pregnancy was detected and/or confirmed, they point out. Also, there are only limited data on exposure in the second and third trimesters.

Biogen said in their release that the risk of spontaneous abortion in pregnant women exposed to interferon-β can't be adequately assessed based on the currently available data, but the data do not suggest an increased risk so far.

Both companies note that levels of interferon-β excreted in breast milk are negligible and no harmful effects on the breastfed newborn/infant are anticipated.

"The interferon-β label update is critically important because now physicians have options for treating women with relapsing MS into the beginning of pregnancy and if clinically needed during pregnancy and breastfeeding," Kerstin Hellwig, Department of Neurology, St Josef Hospital, Bochum, Germany, said in a Merck news release announcing the committee's decision.

"Interferon-β therapy has been approved for more than 20 years and, in that time, vital data have been collected that provide patients and physicians the confidence to consider treatment with interferon beta in this setting," said Hellwig.

"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," Alfred Sandrock, Jr, MD, PhD, executive vice president and chief medical officer at Biogen, said in the company's release.

"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," Sandrock said. "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."

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