Swedish Orphan Biovitrum’s New Study on Anakinra: A Potential Game-Changer for FMF Treatment

Swedish Orphan Biovitrum Ab ((GB:0MTD)) announced an update on their ongoing clinical study.

Study Overview: Swedish Orphan Biovitrum is conducting a study titled A Prospective, Open-label, Single Arm, Multicenter, Post-authorization Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Colchicine-resistant Familial Mediterranean Fever (FMF). The study aims to evaluate the efficacy and safety of anakinra in patients who do not respond to colchicine, a common treatment for FMF. This research is significant as it addresses a critical need for alternative treatments in this patient population.

Intervention/Treatment: The study tests the drug Anakinra, administered as a subcutaneous injection. It is intended to provide relief for patients with colchicine-resistant FMF by reducing inflammation and managing symptoms more effectively.

Study Design: This is an interventional study with a single-group assignment. There is no masking involved, meaning both researchers and participants know what treatment is being administered. The primary purpose of the study is treatment-focused, aiming to assess the therapeutic benefits of Anakinra.

Study Timeline: The study is not yet recruiting, with the first submission date on October 8, 2024. The last update was submitted on June 13, 2025. These dates are crucial as they indicate the study’s progression and readiness to begin enrolling participants.

Market Implications: If successful, this study could positively impact Swedish Orphan Biovitrum’s stock performance by expanding their market presence in China and providing a new treatment option for FMF. Investors may view this as a strategic move to capture a niche market, potentially boosting confidence in the company’s innovation capabilities. Competitors in the rare disease treatment sector will likely monitor these developments closely.

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