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

Teva Pharmaceuticals Europe BV, a European chapter of Teva Pharmaceutical DiligenceLtd. (NYSE and TASE TEVA) andSt. Josef Hospital – Katholisches Klinikum Bochum (Bochum, Germany), presented moment at ECTRIMS congress new analyses of the COBRA study, a real- world substantiation study on the safety of COPAXONE ® (glatiramer acetate or GA) used by maters with multiple sclerosis (MS) during gestation and breastfeeding.
The new analysis of COBRA study, which presently represents the largest dataset of child issues breastfed by maters treated with GA, assessed 99 maters with MS and their babies. It concluded that no substantiation was plant to suggest that babies were negatively affected by motherly exposure to GAduring gestation and breastfeeding with regard to hospitalisations and antibiotic treatments, experimental detention, or growth in the first 18 months of life1.

Professor Kerstin Hellwig, Star Study Investigator, Department of Neurology,St. Josef Hospital, Ruhr University Bochum, Germany noted
.“ Our new analysis, which included 50 seed in the GA group and 50 in a control group ( seed of maters with MS not treated with any complaint- modifying treatment during gestation and breastfeeding), is an important donation to the significant unmet medical need. There’s historically limited clinical safety data for babies who are breastfed by maters witnessing treatment for MS including during the gestation period. We plant no substantiation that GA exposure was associated with experimental detention, body growth issues or increased hospitalisation and antibiotic use in group of babies from the GA cohort in comparison with controls.

“ Half of all MS gravidity are unplanned, so a woman is on average exposed to complaint modifying curatives (DMTs) in the first 30 days of her child’s development until she discovers her gestation and the treatment can be discontinued. Whilere-staring DMT during breastfeeding, a mama has enterprises whether her exposure to DMT during gestation and breastfeeding may harm her child. Our new analyses of the COBRA study give data that accretive motherly exposure to GA during gestation and breastfeeding didn’t negatively 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 Gestation Registry (DMSKW) from 2011 to 2020. Cases were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were suckling under GA treatment (COPAXONE ® 20 or 40 mg/ mL) or breastfeeding under no DMT treatment.

Danilo LemboM.D. VP Medical Europe, Teva Pharmaceuticals comments “ The onset of multiple sclerosis (MS) occurs in women between the periods of 20 and 40 times old; thus, MS affects women during a crucial 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 charge at Teva is to ameliorate the lives of cases, supporting them with important drugs throughout life’s stages, and during family planning in particular.”
The data donation follows expansive ongoing study of COPAXONE ® in a variety of real- world settings that seek to ameliorate treatment decision timber. Ultramodern approaches in the care of women with MS after child birth currently include that croakers inform them about the benefits of suckling for both the mama with MS and her seed; encourage the mama to breastfeed if possible; and eventually support the case and her decision.”

COPAXONE ® (glatiramer acetate injection) is indicated for the treatment of cases with relapsing forms of multiple sclerosis. The most common side goods of COPAXONE ® are greenishness, pain, lump, itching, or a lump at the point of injection, flushing, rash, briefness of breath, and casket pain. A decision must be made whether to discontinue bone-feeding or to discontinue/ hesitate from Copaxone remedy taking into account the benefit of bone feeding for the child and the benefit of remedy for the woman.

About Teva
Teva Pharmaceutical DiligenceLtd. (NYSE and TASE TEVA) has been developing and producing drugs to ameliorate people’s lives for further than a century. We’re a global leader in general and specialty drugs with a portfolio conforming of over products in nearly every remedial area. Around 200 million people around the world take a Teva drug every day and are served by one of the largest and most complex force chains in the pharmaceutical assiduity. Along with our established presence in generics, we’ve significant innovative exploration and operations supporting our growing portfolio of specialty and biopharmaceutical products.

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