Teva (TEVA) Announces COPAXONE Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

Teva Pharmaceuticals (NYSE: TEVA) Europe BV confirms 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 product is now approved by EU health authorities for use in breastfeeding. 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

COBRA, the largest standardized 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 says: “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 comments: “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.”

Notes to editors

About the COBRA Study

“Real-world safety of COPAXONE® in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) patients” (COBRA study) was retrospective data analysis using the national German Multiple Sclerosis and Pregnancy Registry. 60 offspring from the Glatiramer Acetate (GA) cohort (59 pregnancies; 58 women) and 60 from the control (60 pregnancies; 60 women) were included. Maternal demographics and RMS prognostic factors were descriptively comparable between cohorts. “Cumulative” maternal COPAXONE® exposure was higher in the GA cohort vs control, because 86.7% of offspring’s mothers received GA also at some point during pregnancy (vs 25%).

Safety outcomes in ≤18 months of postpartum follow up showed similar frequency and incidence of hospitalisations for both cohorts. Annualized number of hospitalisations was 0.20 [95% confidence interval {CI}=0.09–0.31] in the GA cohort vs the control (0.25 [95% CI=0.12–0.38]). 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 time point studied. Paediatrician check-ups at 12 months identified 3 (2.5%; N=120 [95% CI=0.52–7.13]) offspring with developmental delays; all in the control cohort (n=60; 5% [95% CI=1.04–13.92]).

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