Rolling BLA is submitted to the FDA for SEL 212 (rapamycin + pegsiticase) for the potential treatment of chronic refractory gout
Sobi announced the initiation of a rolling Biologics License Application (BLA) to the 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 characterised by the persistent and painful buildup of urate crystals in the joints.
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.
SEL 212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which can lead to gout flares and joint deformity when left untreated. Sobi licensed SEL 212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China.
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