Sobi Begins FDA Submission Process for SEL-212, Advancing Potential Treatment for Chronic Refractory Gout
Sobi has commenced a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212, based on positive outcomes from the DISSOLVE I and II pivotal trials. SEL-212 represents an innovative biologic therapy aimed at addressing chronic refractory gout, a painful condition characterized by persistent urate crystal accumulation in the joints.
This milestone follows the FDA’s Fast Track designation of SEL-212 in March 2024, highlighting the urgent need for new therapeutic options in chronic refractory gout. The Fast Track program expedites the review of medicines for serious conditions with unmet medical needs.
Dr. Lydia Abad-Franch, MD, MBA, head of research, development, and medical affairs, and chief medical officer at Sobi, expressed enthusiasm about advancing SEL-212 towards potential approval. She emphasized the significance of the Fast Track designation in validating the phase 3 clinical data and reinforcing Sobi’s commitment to enhancing patient outcomes in rare diseases.
SEL-212 combines pegadricase, Selecta’s pegylated uricase, with ImmTOR to potentially lower serum urate levels and prevent urate deposits that trigger gout flares and joint damage. Sobi acquired SEL-212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 and manages its development, regulatory, and commercial activities globally except in China.
Gout affects over 8.3 million people in the US, with approximately 200,000 suffering from chronic refractory gout resistant to conventional treatments. Elevated uric acid levels associated with gout are linked to various serious health issues.
Sobi, a specialized biopharmaceutical company, focuses on delivering innovative treatments in haematology, immunology, and specialty care to improve the lives of patients with rare and debilitating diseases.