EMA approves interferon beta treatments, including Rebif (interferon beta-1a), for relapsing MS patients during pregnancy and breastfeeding

Posted in Industry News on 22nd Oct 2019

  • EMA approval makes interferon beta, including Rebif (interferon beta-1a), a treatment option for relapsing multiple sclerosis that may be continued into pregnancy if clinically needed and while breastfeeding1,2
  • Approval is based on data from more than 1,000 real-world pregnancy outcomes1
  • MS is most often diagnosed between the ages of 20-40,3 during childbearing years

London – UK, 21 October 2019 – Merck announced that the European Medicines Agency (EMA) has approved an update to the product label of Rebif®, an interferon beta-1a, to include that women with relapsing multiple sclerosis (RMS) may continue treatment with Rebif® (interferon beta-1a) during pregnancy if clinically needed, and also while breastfeeding.1,2

MS is a chronic disease affecting twice as many women as men and is often diagnosed between the ages of 20-40 years.3 A survey of women throughout Europe showed that more than one third of women with MS decided not to have children or altered the timing for having children due to concerns related to their MS.4

The label update has removed the previous contraindication against treatment initiation during pregnancy as well as the requirement to use contraception while on Rebif® (interferon beta-1a). Rebif® (interferon beta-1a) can now also be used during breastfeeding, another important area of unmet need for mothers with MS who wish to breastfeed. According to the new label, levels of interferon beta excreted in breast milk are negligible. No harmful effects on the breastfed newborn/infant are anticipated.1,2

Professor Jeremy Hobart, consultant neurologist at Plymouth Hospitals NHS Trust said: “It’s a win-win for women living with MS. The interferon beta label update represents yet another important step in the history of MS care.  MS is predominantly a disease of women in their childbearing years: juggling the desires for disease control and families has historically been very challenging and deeply troubling for female patients. Now, physicians have more options for treating women with relapsing MS into the beginning of pregnancy and, if clinically needed, during pregnancy and breastfeeding, giving women living with MS – and their clinicians – more confidence that they can have both children and disease control.”

David Martin, Chief Executive Officer of the Multiple Sclerosis Trust added: “MS is most often diagnosed between 20 and 40 years old, at a time when women may be planning to have children. Delaying disease modifying treatment until after having a family can lead to irreversible disability in the long term. Many women living with relapsing MS will be reassured to know that they have the option to start or continue Rebif while pregnant or breastfeeding.”

More than 1,000 pregnancy outcomes from registries and post-marketing experience indicate no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or exposure during the first trimester of pregnancy.1 It should be noted that 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. Experience with exposure during the second and third trimesters is very limited. Based on animal data, there is a possibly increased risk for spontaneous abortion. 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.1

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide.

Rebif® can be administered with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose® single-use disposable pen. Rebif® can also be administered with the autoinjector Rebiject II® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif® in early multiple sclerosis.

Rebif® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide2, and 100,000 in the UK4. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

 

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck generated sales of € 14.8 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

 

About the Multiple Sclerosis Trust

The Multiple Sclerosis Trust fights to make sure everyone affected by MS can access good quality, specialist care and live the best life they possibly can. It supports and trains MS health professionals and funds MS specialist nurses and Advanced MS Champions across the UK. The MS Trust also produces practical, evidence-based information, online and in print, and its dedicated Enquiry Service team are a friendly and knowledgeable voice to speak to for anyone who needs to know more about MS. To find out more about the MS Trust’s work supporting everyone affected by MS, visit www.mstrust.org.uk.

 

1 https://www.ema.europa.eu/en/documents/procedural-steps-after/rebif-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf

2 https://www.ema.europa.eu/en/medicines/human/EPAR/rebif (accessed 18 October 2019)

3 MS International Foundation. Who Gets MS? https://www.msif.org/about-ms/epidemiology-of-ms/ (accessed 14 October 2019).

4 Merck KGaA, Darmstadt, Germany. The socioeconomic impact of multiple sclerosis on women in Europe. https://www.emdgroup.com/content/dam/web/corporate/non-images/press-releases/2017/oct/us/The-socioeconomic-impact-of-MS-on-women-in-Europe-US.pdf  (14 August 2019)

5 MS Trust. MS in the UK. https://www.mssociety.org.uk/care-and-support/resources-and-publications/publications-search/ms-in-the-uk (accessed 14 October 2019)

 

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