Sobi Commences Rolling BLA Application to US FDA For SEL-212

Sobi declared the commencement of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212. The pivotal studies DISSOLVE I and II served as the foundation for the submission. For the treatment of chronic refractory gout, a debilitating condition marked by the persistent and painful buildup of urate crystals in the joints, an innovative biologic therapy called SEL-212 is currently in development.

This significant milestone highlights the urgent need for new treatment options for patients with chronic refractory gout and follows the FDA's Fast Track designation of SEL-212 in March 2024. The FDA's Fast Track program is expected to work with the turn of events and facilitate the review of medicines that treat difficult circumstances and fill a unmet medical need.

"We are very pleased to initiate the rolling submission of the BLA for SEL-212, bringing Sobi one step closer to providing a potential new, effective treatment option for patients with chronic refractory gout," said Lydia Abad-Franch, MD, MBA, head of research, development, and medical affairs, and chief medical officer at Sobi. "The Fast Track designation confirms the previously released SEL-212 phase 3 clinical data, highlighting the significant need for innovative therapies in this space and reinforcing our commitment to transforming the lives of patients with rare diseases."

SEL-212 is a novel investigational combination drug that aims to lower serum urate (SU) levels in people who have chronic refractory gout. This could help reduce harmful tissue urate deposits that can cause flare-ups and joint deformity if left untreated.