COPAXONE® label updated to help breastfeeding mothers with relapsing MS
The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
Teva Pharmaceuticals Europe BV has confirmed that the SmPC for COPAXONE® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated.
The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.ii
The product is now approved by EU health authorities for use in breastfeeding.
COBRA, the largest standardised analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life.iii The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.
Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany, said: “The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, but historically there has been limited clinical safety data for infants breastfed by mothers undergoing MS treatment. It is now believed breastfeeding could be protective for mothers with MS. The COBRA study results support mothers with MS in their choice to breastfeed without having to preclude MS treatment. This is an important contribution to current significant medical need.”
There are almost half a million women in Europe living with MS1; it is most common during childbearing age and about half of mothers with MS start their families after diagnosis. The pregnancy rate in MS is constantly increasingiv and recent research shows pregnancy does not worsen the disease progression (which traditionally has been a concern for patients).v
However, studies have found an increase in relapse incidence after child birth, in the postpartum periodvi, so MS treatment may need to be resumed. The majority of MS therapies’ labels advise against breastfeeding, so mothers are often faced with a choice to breastfeed their babies or restart their treatment. Given that according to a U.S. study approximately half of women with MS want to breastfeed vii, the safety of medications used to treat MS while breastfeeding is of concern to mothers. A further treatment option that can be used during breastfeeding may help address a significant medical need for mothers with MS.
Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals, commented: “Our mission at Teva is to improve the lives of patients. This includes addressing gender inequalities in healthcare and understanding the unique challenges that women face during pregnancy and breastfeeding. The COPAXONE® label change provides breastfeeding patients with MS the choice to breastfeed while on 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 therapy for relapsing multiple sclerosis. Eur.J.Neurol. 2021; 28(SUPPL 1): 201-202. 10.1111/ene.14973
iii) Teva Pharmaceutical Industries Limited, 2021. New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live 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 & other CNS Inflammatory Diseases p. 773-792 June 2019, 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 Do We Improve Patient Education? European Neurological Review. 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.