EU Copaxone Label No Longer Advises Against Use During Breastfeeding

The label of Copaxone (glatiramer acetate) — an approved therapy for relapsing forms of multiple sclerosis (MS) — has been updated in Europe to no longer contain a warning against its use during breastfeeding.

The label update follows a review by European Union health authorities of non-clinical and clinical evidence submitted last year by Teva Pharmaceuticals, Copaxone’s developer. These included the latest data from the COBRA real-world study, which found no signs of adverse outcomes in infants breastfed by mothers with MS who were on Copaxone.

With this update, neurologists and other healthcare professionals treating women with MS have access to Copaxone’s safety data in the real-world setting, which favors a positive benefit/risk balance during breastfeeding.

“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,” Kerstin Hellwig, MD, COBRA’s principal investigator, said in a press release.

“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,” added Hellwig, who is a senior consultant neurologist and a researcher at Ruhr University’s St. Josef Hospital, in Germany.

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Notably, the therapy’s label in Europe also was updated in 2016 to remove a similar warning regarding its use during pregnancy.

In the U.S., Copaxone’s label states that are no available or sufficient data to draw conclusions on the safety and effects of the therapy during pregnancy and breastfeeding.

“The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COPAXONE and any potential adverse effects on the breastfed infant
from COPAXONE or from the underlying maternal condition,” it states.

Given that MS affects two to three times more women than men, and that female patients are often diagnosed during childbearing age, pregnancy is a top consideration when choosing a treatment plan.

While pregnancy is known to protect women from MS relapses, relapse rates increase significantly after pregnancy — especially during the first three months — supporting the need for a swift restart of disease-modifying therapies (DMTs).

However, the labels on most DMTs advise against use during breastfeeding, forcing most mothers to choose between breastfeeding their babies or restarting their treatment. Having DMTs that can be used during breastfeeding may help address a significant medical need for mothers with MS.

Danilo Lembo, MD, the vice president of Europe medical affairs at Teva said: “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,” Lembo added.

Copaxone is an approved DMT for relapsing forms of MS that is given through an under-the-skin (subcutaneous) injection at a dose of 20 mg/mL, once a day, or 40 mg/mL, three times a week.

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COBRA — standing for Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis pAtients — involved the retrospective analysis of 2011–2020 data from the national German MS and Pregnancy Registry.

The researchers looked at the safety outcomes of 120 infants whose mothers were receiving either Copaxone (58 women, 59 pregnancies) or no DMT (60 women, 60 pregnancies) while breastfeeding.

Results showed no significant differences in the infants from the two groups in any area. Specifically, there were no key differences in terms of number of hospitalizations, antibiotics use, developmental delays, and growth parameters in the first 18 months of life.

Notably, only three infants had developmental delays at one year, and all were from the group of mothers who were not on DMT.

These findings highlighted that there was no evidence that infants were adversely affected by maternal exposure to Copaxone during breastfeeding.

In addition, a higher proportion of infants in the Copaxone group also were exposed to the therapy during pregnancy compared with those whose mothers were not on DMT during breastfeeding (86.7% vs. 25%).

These results further suggest that Copaxone is safe for both fetuses and infants during breastfeeding ages.