Commercial The Product Summary of COPAXONE® overhauled as new data...

The Product Summary of COPAXONE® overhauled as new data surfaces


The label has been updated to help breastfeeding mothers with relapsing Multiple Sclerosis(MS) following the revaluation of clinical and non-clinical data including the recent COBRA study

Teva Pharmaceuticals Europe has announced that the Summary of Product Characteristics (SmPC) of COPAXONE® has been refurbished.

COPAXONE® (Glatiramer Acetate (GA) injection) has been put to use in treating the relapsing form of Multiple Sclerosis. Analysis has been done of clinical and non-clinical data investigating the safety measures in infants being breastfed by mothers diagnosed with MS on GA medication during the first 18 months of the infant’s life. 

EU health authorities have allowed breastfeeding mothers to use COPAXONE®. 

COBRA, the biggest standardized examination of information from the National German Multiple Sclerosis and Pregnancy Registry, evaluated safety results in a sum of 120 newborn children including 60 of them breastfed by moms under GA. It reasoned that no proof was found to propose that newborn children were adversely impacted by maternal use of GA during breastfeeding. This was estimated by the number of hospitalizations, antibiotic use, growth delays, and developmental parameters in the initial year and a half of life.  The mark update gives data to neurologists and other medical care experts treating MS patients of GA’s positive advantage/hazard balance in breastfeeding.

Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany, said: “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 needs.”

Around 500,000 European women are suffering from MS which is common during childbearing age. Many mothers with MS start their families after diagnosis. The pregnancy rate in MS is continually on the ascent and ongoing research shows pregnancy doesn’t accelerate disease progression (which generally has been a worry for patients).

Notwithstanding, studies have observed an increment in relapse frequency after labor, in the postpartum stage, so MS treatment should be continued. Most MS treatments advise against breastfeeding, so moms are frequently confronted with a decision to breastfeed their children or restart their treatment. As indicated by U.S. research, 50% of women living with MS want to breastfeed, the side effects of drugs used to treat MS are of worry to moms who breastfeed. Another therapy choice that can be utilized during breastfeeding may prove beneficial in this critical clinical requirement for moms with MS.

One of the leading officials of Teva Pharmaceuticals noted “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.”

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