AstraZeneca’s Anifrolumab PRIM Program: Monitoring Pregnancy Outcomes

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 Anifrolumab PRIM Program aims to monitor pregnancy and infant outcomes in pregnancies exposed to Anifrolumab, a drug used for treating systemic lupus erythematosus (SLE). The study, titled ‘Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data,’ seeks to gather comprehensive safety data to ensure the well-being of both mothers and infants.

Intervention/Treatment: The study focuses on Anifrolumab, a human monoclonal antibody targeting the type 1 interferon receptor, which has shown efficacy in reducing disease activity in SLE patients. The drug is already approved by the FDA and EMA for treating moderate to severe SLE.

Study Design: This observational study will prospectively collect data on pregnancies exposed to Anifrolumab, starting from 16 weeks before conception until pregnancy outcome. It will use intensive monitoring to gather detailed safety information on both pregnancy and infant outcomes.

Study Timeline: The study is set to start on September 30, 2025, with the latest update submitted on June 24, 2025. These dates are crucial as they mark the beginning of data collection and the most recent information available, indicating the study’s progress.

Market Implications: This study could influence AstraZeneca’s stock performance by providing critical safety data that may affect Anifrolumab’s market position. Positive outcomes could enhance investor confidence and strengthen AstraZeneca’s competitive edge in the SLE treatment market, especially against other pharmaceutical companies developing similar therapies.

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