The U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS).
The label update draws on findings from a large population-based study, together with other studies published over several decades, and was done in accordance with the FDA’s Pregnancy and Lactation Labeling Rule. This rule provides prescribers with relevant information for critical decision-making when treating pregnant or lactating women.
The new Rebif label will no longer carry the pregnancy Category C designation to now include data that helps healthcare providers weigh treatment risk, and to support the counseling of pregnant women and nursing mothers.
“At EMD Serono, we are dedicated to supporting women with MS at every stage of their life journey, including when planning to start or expand their families,” Maria Rivas, MD, global chief medical officer and senior vice president at EMD Serono, said in a press release. “Today’s update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives.”
Given that more than half of women with relapsing MS are of childbearing age, pregnancy is a top consideration when choosing a treatment plan. The disease affects twice as many women as men, and is often diagnosed when patients are between ages 20 and 40. About one-third of female patients have discussed with their doctors plans to conceive within the next three years.
“Women with MS often have concerns and questions for their doctors about continuing disease-modifying treatments as they are trying to conceive, or if they do become pregnant,” said Maria Houtchens, MD, an associate professor of neurology at Brigham and Women’s Hospital.
“The inclusion of pregnancy outcomes and lactation data in the Rebif label provides valuable insights. I believe it will encourage discussions between physicians and their patients about MS treatment options when considering pregnancy,” Houtchens added.
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