Teva Pharmaceutical Industries Ltd (NYSE: TEVA) and St. Josef Hospital have presented the results of the COBRA study at EAN Congress and offered new insight regarding COPAXONE® (glatiramer acetate) use in breastfeeding mothers with multiple sclerosis.
The study evaluated 120 mothers and their infants.
The study assessed 120 moms with MS and their kids, representing the most extensive child outcomes analysis nursed by mothers under GA. Findings showed that there was no indication of maternal exposure to glatiramer acetate. At the same time, breastfeeding had no adverse effect on infants’ hospitalizations, developmental delay, antibiotic treatments, or growth in the first one and half years.
Kerstin Hellwig, the study’s principal investigator Neurology Department, St Josef Hospital, said that breastfeeding has clinically significant and well-documented benefits for both mothers and their children. Therefore it’s critical to offer clinical evidence on the safety of disease-modifying treatments (DMTs) so that MS mothers don’t have to stop breastfeeding while on treatment.
Hellwig stated that, in light of the global COVID-19 pandemic, the study makes a significant contribution to this significant unmet medical need. Infants nursed by mothers undergoing MS treatment have had inadequate clinical safety data in the past. In comparison to controls, the study discovered no evidence of developmental delay, body growth difficulties, or higher hospitalization and antibiotic use in the glatiramer acetate cohort of newborns.
Teva is committed to helping nursing mothers.
Teva Pharmaceuticals VP Medical Europe, Danilo Lembo, said they are delighted for the study and its accomplishments. One in every three women with MS may experience illness reactivation following childbirth, according to published data. Most patients prioritize slowing the disease’s progression, preventing relapses, and nursing, especially during the vulnerable time. Lembo said that Teva’s purpose is to make patients’ lives better. As a result, that includes assisting people in getting the most out of vital medications at all times of life, especially during family planning.