Business Wire

New Register-based Data on Use of Interferon Beta, Including Rebif®, in Women with Multiple Sclerosis Show No Effect on Pregnancy Outcomes

Share

Merck, a leading science and technology company, today announced that new data on pregnancy outcomes at birth after exposure to interferon beta (IFN β), including Rebif® (sc/subcutaneous interferon beta-1a), will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Results showed no evidence that IFN β-exposure before and during pregnancy in women with multiple sclerosis (MS) affected infant birth weight for gestational age and head circumference. The results are based on data from Finnish and Swedish health registers collected between 1996-2014.

“Our priority is ensuring we address the needs of people living with MS,” said Dr. Maria Rivas, Chief Medical Officer at Merck. “When a woman is diagnosed with MS she may have questions on continuing treatment during pregnancy and how it could affect her unborn child. We are proud to collaborate with academia and health authorities to provide relevant safety information to physicians and patients.”

Among 666 IFN β-exposed and 1,330 unexposed live births, the prevalence of pregnancy outcomes were similar and not statistically different between the IFN β-exposed versus the unexposed patients. The prevalence of small for gestational age in the exposed cohort was 2.1% (95% CI 1.2-3.5) versus 2.0% (95% CI 1.3-2.9) for the unexposed, and large for gestational age was 0.8% (95% CI 0.2-1.7) for the exposed versus 0.8% (95% CI 0.4-1.5) for the unexposed. The prevalence of low birth weight was 3.9% (95% CI 2.6-5.7) among IFN β-exposed and 4.8% (95% CI 3.7-6.1) among the unexposed. Among 619 IFN β-exposed and 1,219 unexposed full-term births, the prevalence of low head circumference was 1.9% (95% CI 1.0-3.4) among the IFN β-exposed versus 1.1% (95% CI 0.6-1.8) among the unexposed.

These data points expand on safety data presented at recent congresses, which suggest exposure to IFN β does not increase risk of spontaneous abortions or affect other pregnancy outcomes, such as ectopic pregnancies or fetal malformations.

“Most women are diagnosed with MS at a time in their lives when they may be thinking about starting or extending a family, making their treatment decision more complex,” said Professor Kerstin Hellwig, Department of Neurology at St. Josef Hospital, Germany. “These data add to our wealth of knowledge to better understand the safety of interferon beta treatment during pregnancy.”

In the EU, the initiation of Rebif during pregnancy is currently contraindicated by the European Medicines Agency (EMA), see section 4.3 and 4.6 in the EU Summary of Product Characteristics (SMPC) for Rebif. Merck has submitted regulatory filings with different health authorities to include safety data from these interferon registries in the Rebif label, and these reviews are currently ongoing.

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. Interferon ß is thought to help reduce inflammation. 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® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area.

Rebif® can be administrated with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose® single-use disposable pen, or the manual multidose injection pen RebiSlide™. 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. The extension of the indication of Rebif® has not been submitted in the United States. 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 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.

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).

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

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.

1 MS International Foundation. Who Gets MS? https://www.msif.org/about-ms/epidemiology-of-ms/. Accessed 14 August 2019
2 MS International Foundation. What is MS? https://www.msif.org/about-ms/what-is-ms/. Accessed 14 August 2019.

Contact information

Tone Brauti Fritzen
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Lattice Sentry Solutions Stack and SupplyGuard Service Deliver End-to-End Supply Chain Protection with Dynamic Trust12.8.2020 22:00:00 CESTPress release

Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today launched the Lattice Sentry™ solutions stack and the Lattice SupplyGuard™ supply chain protection service. The Sentry stack is a robust combination of customizable embedded software, reference designs, IP, and development tools to accelerate the implementation of secure systems compliant with NIST Platform Firmware Resiliency (PFR) Guidelines (NIST SP-800-193). The Lattice SupplyGuard service extends the system protection provided by the Sentry stack throughout today’s challenging and rapidly changing supply chain by delivering factory-locked devices to protect them from attacks like cloning and malware insertion, and enables secure device ownership transfer. These hardware security solutions are increasingly important to a range of applications, including communications, datacenter, industrial, automotive, aerospace, and client computing. This press release features multimedia. View the full rel

Phase III InPedILD™ trial enrolls first patient to evaluate nintedanib in pediatric population with fibrosing interstitial lung disease12.8.2020 14:36:00 CESTPress release

Boehringer Ingelheim today announced that the first patient has enrolled in InPedILD™, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD). Childhood ILD (chILD) includes more than 200 rare respiratory disorders that can affect infants, children and adolescents, making it difficult for them to breathe. In some cases, fibrosis which involves scarring and damage to the lungs can develop. This can lead to a significant impact on the daily life of those affected, as well as their families, including high morbidity and mortality. There are currently no approved therapies available for the treatment of chILD. “Some children with interstitial lung disease may develop serious fibrosis that progresses,” said the coordinating investigator Prof. Robin Deterding, M.D., Director of the Breathing Institute, Children's Hospital Colorado. “Though the

Velodyne Lidar Powering Intelligent Traffic Management in Nevada12.8.2020 14:00:00 CESTPress release

Velodyne Lidar, Inc. today announced a partnership with University of Nevada, Reno to advance research in transportation infrastructure. The university’s Nevada Center for Applied Research purchased and, in conjunction with the Nevada DOT and Nevada Governor’s Office of Economic Development, is using Velodyne’s lidar sensors in its Intelligent Mobility initiative to collect data aimed at making transportation more efficient, sustainable and safe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005076/en/ The University of Nevada, Reno’s Nevada Center for Applied Research has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic. (Photo: Velodyne Lidar, Inc.) The program has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic to help improve traffic analytics, congestion mana

Moody’s Analytics Three-Peats in Two Categories at Risk Technology Awards12.8.2020 13:30:00 CESTPress release

For the third straight year, Moody’s Analytics has won the Risk Technology Awards for Credit Data Provider of the Year and Wholesale Credit Modelling Software of the Year. These are two of our seven 2020 Risk Technology Awards spanning finance, accounting, regulatory, and credit functions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005119/en/ “Our clients rely on Moody’s Analytics for a fast and comprehensive view of their credit risk exposure,” said Nihil Patel, Managing Director at Moody’s Analytics. “The pandemic has accelerated their need to consider multiple forward-looking signals to assess credit risk. We continue to invest—in more asset class coverage, in alternative data sources, in machine learning that produces new analytics and insights—to ensure that our clients have all the information they need to address their most pressing business needs.” Extensive credit data and modeling capabilities feature in

Imricor Announces Sales Collaboration with Optoacoustics12.8.2020 13:00:00 CESTPress release

Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in MRI-guided cardiac ablation products, is pleased to announce a sales collaboration with Optoacoustics Ltd, the world leader in innovative, high performance optical communication solutions for magnetic resonance (MR) applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005231/en/ Imricor Announces Sales Collaboration With Optoacoustics (Photo: Business Wire) The collaboration establishes a formal relationship between Imricor and Optoacoustics to facilitate the introduction of the IMROC IRTM Wireless Multichannel Communication System to Imricor customers. IMROC provides wireless noise cancelling MRI headsets that can be used by up to 8 participants simultaneously, including the patient. The system was developed specifically for use in iCMR environments. Given the noise and complexities of MRI, normal conversation can be difficult d

Samsung Display Commercializes New, Variable Refresh Rate Technology for Increasing Smartphone Power Savings12.8.2020 10:19:00 CESTPress release

Samsung Display Company today revealed new display technology that features a remarkable power-saving function for mobile electronics, being commercialized for the first time in Galaxy Note 20 Ultra 5G flagship smartphones. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005278/en/ Engineers from Samsung Display are using testing devices to inspect frequency changes in display panels that feature adaptive frequency technology (Photo: Business Wire) The display company has now successfully commercialized its low-power OLED adaptive frequency technology, which can curtail the operating power of a phone’s display by as much as 22 percent over existing smartphones now in general use. “High-definition video streaming and gaming are expanding their capabilities in line with 5G commercialization, creating a widespread need for display panel technologies that can enable greater power savings,” said Ho-Jung Lee, Vice President o