Sobi announced the submission of a rolling biologics license application (BLA) to the FDA for SEL-212 (Sobi), a novel investigational combination medicine for the treatment of chronic refractory gout (CRG). The BLA submission follows the FDA Fast Track designation of SEL-212 in March 2024.1
The BLA submission was based on results from the phase 3 DISSOLVE 1/2 placebo controlled, randomized pivotal studies that determined the safety and efficacy of 2 dose levels of SEL-212 in adult patients with CRG. The DISSOLVE 1 study met its primary end point with a 56% response rate in patients that received a monthly dose of 0.15 mg/kg of SEL-212. Additionally, the DISSOLVE 2 study also met its primary end point with a response rate of 47% among individuals treated with the same monthly dose.2
“The Fast Track designation confirms…