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Interferon Beta Treatments Receive Positive CHMP Opinion for Use in Relapsing Forms of Multiple Sclerosis (MS) During Pregnancy and Breastfeeding

Posted in Industry News,News Review on 25th Sep 2019

  • Positive opinion is supported by data from more than 1,000 real-world pregnancy outcomes1,2
  • Data indicate no increased risk of major congenital anomalies after exposure to interferon beta before conception and/or during first trimester1,2
  • Data show pregnancy outcomes are in line with general population1,2

Maidenhead, UK. – 23rd September 2019 – Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the marketing authorisations of approved interferon beta treatments, including peginterferon beta-1a and interferon beta-1a, to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS).

Women are twice as likely to get MS than men3, with many diagnosed in their twenties and thirties – a time when they may be considering starting a family. The ability to choose a treatment plan that allows women to continue or start their MS therapy while pregnant or breastfeeding is an important step forward for those living with this chronic, debilitating disease, their partners, and their healthcare professionals. We are delighted that the CHMP’s positive opinion, based on data from over 1,000 pregnancy outcomes,1,2 may provide them with greater confidence when considering treatment with peginterferon beta-1a or interferon beta-1a.

Dr. Simon Beck, Medical Director, Biogen UK & Ireland.

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.2

Data collected indicated no increased risk of major congenital anomalies following exposure to interferon beta before conception or during the first trimester of pregnancy.1,2 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.2 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.2 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.4, 5

References

1 Prevalence of Infant Outcomes at Birth After Exposure to Interferon Beta Prior to or During Pregnancy: A Register-based Cohort Study in Finland and Sweden Among Women with MS. Presented at: 2019 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, September 13th 2019, Stockholm, Sweden.

2 Hellwig K, Geissbuehler Y, Sabidó M. Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and MS Pregnancy study conducted in Finland and Sweden. Presented at: 2019 American Academy of Neurology Annual Meeting (AAN). May 4th – 10th, 2019; Philadelphia, PA, USA.

3 Airas L et al. Obstet Med. 2012;5(3):94-97

4 Plegridy (peginterferon beta-1a) draft summary of product characteristics, September 2019

5 Avonex (interferon beta-1a) draft summary of product characteristics, September 2019

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