MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS) This included the acceptability
Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab (SLK) achieving HiSCR75 and up to 32% of patients achieving HiSCR100 An analysis
In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12 Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the Phase 2 LEDA trial The upcoming Phase 3 program will therefore be expected to
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) FDA feedback confirms that the