MoonLake Immunotherapeutics received positive FDA feedback on its planned BLA submission strategy for sonelokimab in hidradenitis suppurativa and expects to file the application by September 2026.
Written By: Regulatory Desk
MoonLake Immunotherapeutics announced that it has received positive feedback from the U.S. Food and Drug Administration during its final pre-BLA meeting regarding the hidradenitis suppurativa (HS) development program for its Nanobody® candidate SLK.
The meeting, held on April 1, 2026, focused on MoonLake’s planned biologics license application (BLA) submission strategy, proposed label content, adolescent patient inclusion, and safety data package. According to the company, the FDA aligned with its proposed regulatory approach across several key areas.
The FDA confirmed the acceptability of including data from the Phase 2 MIRA clinical trial (NCT05322473) as a key component in establishing substantial evidence of effectiveness (SEE). The agency also agreed with MoonLake’s plan to analyze the MIRA data using an approach consistent with that used in the Phase 3 VELA clinical trials.
In addition, the FDA agreed that data from the VELA-TEEN study (NCT06768671) could be included in the BLA submission for adolescent patients with HS. The company said the trial is expected to be considered final and pivotal at the time of the planned submission. Based on this alignment, MoonLake intends to seek a label covering patients aged 12 years and older and has informed the FDA of its intention to request Priority Review.
The agency also agreed with the proposed clinical safety strategy, including the plan to primarily base the safety analysis on pooled data from the Phase 3 VELA-1 (NCT06411899) and VELA-2 trials (NCT06411379). MoonLake stated that the FDA considered the remaining non-clinical studies, safety pools, and analyses appropriate for filing and review.
According to the company, no unresolved issues related to the planned BLA submission were identified, including in Chemistry, Manufacturing, and Controls (CMC) requirements, and no further FDA meetings are currently required.
MoonLake said the proposed label for SLK is expected to include efficacy findings from the MIRA study, including an approximately 43% HiSCR75 response rate and an approximately 29% point improvement versus placebo. The company stated these represent the highest values reported to date in an adequate and well-controlled HS clinical trial.
The company plans to submit the BLA for SLK in adult and adolescent HS patients by the end of September 2026. MoonLake expects the FDA to determine filing acceptance within 60 days of submission and to notify the company at that time whether Priority Review has been granted.
Subject to regulatory approval, MoonLake expects a potential U.S. commercial launch in the second half of 2027.
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