Novo Nordisk’s Refixia® Study: A Closer Look at Long-term Safety and Effectiveness

Novo Nordisk ((NVO)) announced an update on their ongoing clinical study.

Study Overview: Novo Nordisk is conducting a post-marketing surveillance study titled ‘Post-marketing Surveillance (Use Result Surveillance) With Refixia®’. This multicentre, non-interventional study aims to assess the safety and effectiveness of Refixia® in routine clinical care for patients with Haemophilia B in Japan. The significance of this study lies in its focus on long-term safety and effectiveness, crucial for ongoing patient care and treatment optimization.

Intervention/Treatment: The study tests Refixia®, a drug used in the treatment of Haemophilia B. Participants will receive Refixia® as prescribed by their doctors, with the goal of evaluating its long-term safety and effectiveness in real-world clinical settings.

Study Design: This is an observational cohort study with a prospective time perspective. It involves patients with Haemophilia B, both those previously exposed and not exposed to Refixia®. The primary purpose is to observe and gather data on the drug’s performance in routine clinical practice.

Study Timeline: The study began on March 13, 2019, and is currently enrolling by invitation. The primary completion and estimated study completion are set for September 2025. The last update was submitted on September 24, 2025, indicating ongoing data collection and analysis.

Market Implications: This study could have significant implications for Novo Nordisk’s stock performance and investor sentiment. Positive results demonstrating the long-term safety and effectiveness of Refixia® could boost investor confidence and enhance the company’s market position. In the competitive landscape of haemophilia treatments, maintaining a strong safety profile is crucial for Novo Nordisk to differentiate itself from competitors.

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