Sobi initiates rolling biologics license application to FDA for SEL-212

Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, today announced the initiation of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212.

The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout, a debilitating condition characterized by the persistent and painful build-up of urate crystals in the joints, the company explained.

This significant milestone follows the FDA’s Fast Track designation of SEL-212 in March 2024, underscoring the urgent need for new treatment options for patients with chronic refractory gout. The FDA’s Fast Track program is intended to facilitate the development and expedite the review of medicines that treat serious conditions and fill an unmet medical need.