The label update follows the review of clinical and non-clinical evidence, including the latest data from a COBRA real evidence study.
Teva Pharmaceuticals Europe BV has confirmed that the SmPC of COPAXONE® (glatiramer acetate (GA) acetate injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been update.
The label update follows review of clinical and non-clinical evidence, including the latest data from the COBRA real-world evidence study which investigated safety outcomes in breastfed infants. mothers with MS undergoing GA treatment in the first 18 months of life.ii
The product is now approved by EU health authorities for use in breastfeeding.
COBRA, the largest standardized analysis of data from the German National Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants, including 60 breastfed by mothers on GA. She concluded that no evidence was found to suggest that infants were affected by maternal exposure to GA during breastfeeding. This was measured by the number of hospitalizations, antibiotic treatments, developmental delays and growth parameters during the first 18 months of life.iii The label update provides information for neurologists and other healthcare professionals treating MS patients about the positive benefit/risk ratio of GA when breastfeeding.
Professor Kerstin Hellwig, Principal Investigator of the COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany, said: “The benefits of breastfeeding for mothers and their offspring are clinically significant and well documented, but historically , there has been limited clinical safety. data for infants breastfed by mothers on MS treatment. It is now believed that breastfeeding may be protective for mothers with MS. The results of the COBRA study support mothers with MS in their choice to breastfeed without having to rule out MS treatment. This is an important contribution to today’s important medical needs.
Almost half a million women in Europe are living with MS1; it is more common in childbearing age, and about half of mothers with MS start families after diagnosis. The pregnancy rate in MS is steadily risingiv and recent research shows that pregnancy does not worsen disease progression (which has traditionally been a concern for patients).v
However, studies have shown an increased incidence of relapses after childbirth, in the postpartum periodvi, so MS treatment may need to be restarted. The majority of MS treatment labels advise against breastfeeding, so mothers are often faced with the choice of whether to breastfeed their baby or resume treatment. Since according to an American study, about half of women with MS want to breastfeed viiimothers are concerned about the safety of drugs used to treat MS during breastfeeding. Another treatment option that can be used while breastfeeding can help address an important medical need for mothers with MS.
Danilo Lembo MD VP Medical Europe, Teva Pharmaceuticals, said, “Our mission at Teva is to improve the lives of patients. This includes addressing gender inequalities in health care and understanding the unique challenges women face during pregnancy and breastfeeding. COPAXONE® the label change offers breastfeeding patients with MS the choice to breastfeed during their MS treatment.
i) Pugliatti M et al. The epidemiology of multiple sclerosis in Europe. Eur J Neurol 2006;13(7):700-22.
ii) Ciplea A, Kurzeja A, Thiel S, Haben S, Alexander J, Adamus E, Hellwig K. Safety analysis of offspring breastfed by mothers on glatiramer acetate treatment for relapsing multiple sclerosis. Eur.J.Neurol. 2021; 28(SUPPL 1): 201-202. 10.1111/en.14973
iii) Teva Pharmaceutical Industries Limited, 2021. New data on the safety of COPAXONE® (glatiramer acetate) treatment of nursing mothers with relapsing multiple sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN) ). [online] Available at: https://www.tevapharm.com/news-and-media/latest-news/new-safety-data-on-treatment-with-copaxone-glatiramer-acetate-of-breastfeeding-mothers-who-live-with- r/ [Accessed 1 February 2022].
iv) Maria K. Houtchens, MD, Natalie C. Edwards, MSc, Gary Schneider, ScD, Kevin Stern, BA and Amy L. Phillips, Pregnancy Rates and Outcomes in Women with and Without MS in the United States, Neurology® 2018; 91:e1559-e1569. doi:10.1212/WNL.0000000000006384
v) Langer-Gould AM, Multiple sclerosis and other inflammatory diseases of the CNS p. 2019 Jun 773-792, Vol.25, No.3, doi:10.1212/CON.0000000000000745
vi) Manson J. European women with multiple sclerosis feel unprepared and uneducated about family planning and their ability to have children – How can we improve patient education? European Neurological Journal. 2018;13(1):21–4 DOI: https://doi.org/10.17925/ENR.2018.13.1.21
vii) Lorifice L, et al. Neurol Ther 2021; doi: 10.1007/s40120-021-00297-6. Online ahead of print.