AstraZeneca’s PRIMULA Lac Study: Evaluating Anifrolumab’s Impact on Lactation

AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.

Study Overview: AstraZeneca’s PRIMULA Lac study, officially titled ‘Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users,’ aims to assess the presence of anifrolumab in breast milk and serum among lactating individuals. This study is significant as it fulfills FDA post-marketing requirements, focusing on the safety and exposure of anifrolumab in breastfeeding mothers and their infants.

Intervention/Treatment: The study tests Anifrolumab, a human monoclonal antibody targeting the type 1 interferon receptor, used for treating systemic lupus erythematosus (SLE). The purpose is to evaluate its presence and effects in lactating individuals and their infants.

Study Design: This is an open-label, single-group study with no masking, primarily aimed at treatment. Participants include lactating individuals receiving Anifrolumab, with milk and serum samples collected at multiple timepoints to monitor drug presence and effects.

Study Timeline: The study began on August 29, 2025, with an estimated completion date yet to be announced. The latest update was submitted on July 15, 2025. These dates are crucial for tracking study progress and regulatory compliance.

Market Implications: This study could influence AstraZeneca’s stock performance by addressing safety concerns related to Anifrolumab, potentially boosting investor confidence. As the study fulfills regulatory requirements, it may also impact the competitive landscape in the SLE treatment market.

The PRIMULA Lac study is ongoing, with further details available on the ClinicalTrials portal.