AstraZeneca ((AZN)) announced an update on their ongoing clinical study.
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Study Overview: The PRIMULA Lac study, officially titled ‘Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users,’ is a post-marketing requirement study by AstraZeneca. It aims to gather data on the presence of anifrolumab in human breast milk and serum among lactating individuals using the drug. This study is significant as it fulfills FDA requirements and provides crucial insights into the safety of anifrolumab for breastfeeding mothers and their infants.
Intervention/Treatment: The study focuses on anifrolumab, a human monoclonal antibody designed to treat systemic lupus erythematosus (SLE). It works by targeting the type 1 interferon receptor, helping to reduce disease activity in patients with moderate to severe SLE.
Study Design: This interventional study employs a single-group model with no masking. Participants are lactating individuals receiving anifrolumab, and the primary purpose is treatment. The study involves collecting milk and serum samples at specified intervals to assess drug presence.
Study Timeline: The study began on September 10, 2024, with the latest update on September 2, 2025. These dates are crucial as they mark the study’s progress and ongoing data collection efforts.
Market Implications: This study update could positively influence AstraZeneca’s stock, as it demonstrates compliance with regulatory requirements and commitment to patient safety. Investors may view this as a proactive step in addressing potential safety concerns, potentially boosting confidence. Competitors in the SLE treatment market may also be closely monitoring these developments.
The study is currently ongoing, with further details available on the ClinicalTrials portal.