AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
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Study Overview: The PRIMULA Preg study, officially titled ‘Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users,’ is a prospective, observational cohort study by AstraZeneca. It aims to assess the impact of anifrolumab exposure during pregnancy on maternal, fetal, and infant outcomes, particularly in individuals with systemic lupus erythematosus (SLE). This study is significant as it fulfills an FDA post-marketing requirement, providing crucial data on the safety of anifrolumab during pregnancy.
Intervention/Treatment: The study focuses on anifrolumab, a human monoclonal antibody designed to target the type 1 interferon receptor, which plays a role in SLE. Anifrolumab is already approved for treating moderate to severe SLE in adults and is being evaluated for its safety during pregnancy.
Study Design: This is an observational cohort study, meaning it observes outcomes without intervention from researchers. Participants are divided into two groups: those exposed to anifrolumab during pregnancy and those who are not. The study is prospective, looking forward to gather data over time, and aims to collect information from existing medical records without additional tests.
Study Timeline: The study began on August 29, 2025, with an estimated primary completion date yet to be announced. The last update was submitted on July 8, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: This study update could influence AstraZeneca’s stock performance and investor sentiment, as it addresses safety concerns of anifrolumab, potentially expanding its market use. Competitors in the SLE treatment space may also be impacted as safety data becomes available, potentially affecting market dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.