ROCKLAND - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today the U.S. Food and Drug Administration (FDA) has approved the inclusion of new safety data on pregnancy and breastfeeding in the prescribing information for Rebif (interferon beta-1a), in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR).

With a safety profile supported by 20+ years of combined clinical trial data and real-world patient experience, Rebif is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.3

Consistent with the new PLLR requirements, the label for Rebif will no longer have the pregnancy category C designation and contains additional data to assist healthcare providers in assessing benefit versus risk and support counseling of pregnant women and nursing mothers. Patients should continue to notify their healthcare provider if they are pregnant or plan to become pregnant.

'At EMD Serono, we are dedicated to supporting women with MS at every stage of their life journey, including when planning to start or expand their families,' said Maria Rivas, MD, Global Chief Medical Officer, SVP, EMD Serono. 'Today's update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives.'

MS is a chronic disease affecting twice as many women as men and is often diagnosed between the ages of 20-40 years.1 Pregnancy is a key treatment consideration as more than 50 percent of female patients with relapsing MS are of childbearing age and an estimated one-third have discussed planning a pregnancy in the next three years with their healthcare provider.2

'Women with MS often have concerns and questions for their doctors about continuing disease modifying treatments as they are trying to conceive, or if they do become pregnant,' said Maria Houtchens, MD, Associate Professor of Neurology, Brigham and Women's Hospital, Boston. 'The inclusion of pregnancy outcomes and lactation data in the Rebif label provides valuable insights. I believe it will encourage discussions between physicians and their patients about MS treatment options when considering pregnancy.'

The update was based on data from a Nordic register-based study of 2,831 women, as well as a European registry and other published studies over several decades, which have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent.3

Previously, human data on breastfeeding during interferon beta treatment was not available. Now, new, albeit limited, data shows the presence of interferon beta-1a products in human milk at low levels, giving healthcare providers and their patients more information to assist with their decision making. There are no data on the effects of interferon beta-1a on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Rebif and any potential adverse effects on the breastfed child from Rebif or from the underlying maternal condition.3

About Rebif (interferon beta-1a)

Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.

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 worldwide. 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.

EMD Serono, Inc. and Multiple Sclerosis

For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.

About EMD Serono, Inc.

EMD Serono the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

Contact:

Emma Silva

Tel: 1-781-206-1951

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