New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis

COBRA study subgroups results presented at the

37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

• Non-interventional study analysis found no evidence of safety concerns with infants of mothers with multiple sclerosis (MS) who were exposed to glatiramer acetate (GA) treatment during pregnancy and breastfeeding
• Maternal pregnancy and breastfeeding exposure to GA in this study did not adversely affect offspring with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life

AMSTERDAM–(BUSINESS WIRE)–Teva Pharmaceuticals Europe BV, a European affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St. Josef Hospital – Katholisches Klinikum Bochum (Bochum, Germany), presented today at ECTRIMS congress new analyses of the COBRA study, a real-world evidence study on the safety of COPAXONE® (glatiramer acetate or GA) used by mothers with multiple sclerosis (MS) during pregnancy and breastfeeding.

The new analysis of COBRA study, which currently represents the largest dataset of child outcomes breastfed by mothers treated with GA, assessed 99 mothers with MS and their infants. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during pregnancy and breastfeeding with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life¹.

Professor Kerstin Hellwig, Principal Study Investigator, Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany noted:

“Our new analysis, which included 50 offspring in the GA group and 50 in a control group (offspring of mothers with MS not treated with any disease-modifying treatment during pregnancy and breastfeeding), is an important contribution to the significant unmet medical need. There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS including during the pregnancy period. We found no evidence that GA exposure was associated with developmental delay, body growth issues or increased hospitalisation and antibiotic use in group of infants from the GA cohort in comparison with controls.

“Half of all MS pregnancies are unplanned, so a woman is on average exposed to disease modifying therapies (DMTs) in the first 30 days of her child’s development until she discovers her pregnancy and the treatment can be discontinued. While re-staring DMT during breastfeeding, a mother has concerns whether her exposure to DMT during pregnancy and breastfeeding may harm her child. Our new analyses of the COBRA study provide data that cumulative maternal exposure to GA during pregnancy and breastfeeding did not adversely affect the babies regarding the parameters studied within the first 18 months after birth”

The COBRA study used data from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) from 2011 to 2020. Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT treatment.

Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals comments: “The onset of multiple sclerosis (MS) occurs in women between the ages of 20 and 40 years old; therefore, MS affects women during a key moment in their lives when they’re thinking of having children. This is one of the reasons why family planning, is such an important aspect of MS care in women. Our mission at Teva is to improve the lives of patients, supporting them with important medicines throughout life’s stages, and during family planning in particular.”

The data presentation follows extensive ongoing study of COPAXONE® in a variety of real-world settings that seek to improve treatment decision making. Modern approaches in the care of women with MS after child birth nowadays include that physicians inform them about the benefits of breastfeeding for both the mother with MS and her offspring; encourage the mother to breastfeed if possible; and finally support the patient and her decision. ”

References

1. A. Ciplea et. Al, Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis; presented at EAN 2021.
2. Saneea Almas, Jesse Vance, Teresa Baker, and Thomas Hale, Management of Multiple Sclerosis in the Breastfeeding Mother, Multiple Sclerosis International Volume 2016, Article ID 6527458, http://dx.doi.org/10.1155/2016/6527458
3. Pakpoor J, Disanto G, Lacey MV, Hellwig K, Giovannoni G, Ramagopalan, Breastfeeding and multiple sclerosis relapses: a meta-analysis. SVJ Neurol. 2012 Oct; 259(10):2246-8.

About the Study

“Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) pAtients” (COBRA study) is a retrospective data analysis using data of the German Multiple Sclerosis and Pregnancy Registry. In new subgroup analyses, 50 offspring from the glatiramer acetate (GA) cohort (49 pregnancies; 49 women) and 50 from the control (50 pregnancies; 50 women) were included. Maternal demographics and RMS prognostic factors were descriptively comparable between cohorts. “Cumulative” maternal GA-exposure was higher in the GA cohort vs control, because 100% of offspring’s mothers received GA also at some point during pregnancy (vs 26%).

Safety outcomes in ≤18 months of postpartum follow up showed similar results between cohorts, offspring frequency and incidence of hospitalisations. Annualized number of hospitalisations was 0.22 [95% confidence interval {CI}=0.09–0.35] in the GA cohort vs the control (0.26 [95% CI=0.12–0.40]). Frequency and incidence of antibiotic use were similar between cohorts. Growth parameters (body weight, body length and head circumference) were also comparable between cohorts at birth as well as at each of the other five time points studied. Paediatrician check-ups until 12 months identified 2 offspring with developmental delays; all in the control cohort (4%, n=50; [95% CI=0.49–13.71]).

About COPAXONE^®

COPAXONE^® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE^® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Copaxone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE^® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

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