Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- May 11
- 1 min read
10/05/2026
MoonLake Immunotherapeutics announced a positive outcome from its final Pre-BLA meeting with the US FDA for sonelukimab in HS (Ref)
MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the US FDA on the Hidradenitis suppurativa (HS) program for its Nanobody® sonelokimab (SLK; an inhibitor of IL-17A and IL-17F).
During the meeting, MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the BLA, and the safety data strategy.
The FDA re-confirmed the acceptability of including data from the Phase 2, MIRA trial as a key element to establish substantial evidence of effectiveness and to analyze the data consistent with the Phase 3. VELA program approach.
The FDA agreed to the inclusion of VELA-TEEN trial data for adolescent HS patients (≥12 years) in the label proposal, with the trial considered final and pivotal at the time of BLA submission.
The proposed label was expected to include the MIRA trial's ~43% HiSCR75 response and the ~29 percentage-point delta-to-placebo.
Based on this feedback, MoonLake expected to submit the BLA for sonelokimab in adult and adolescent HS to the FDA at the end of September 2026, with acceptance including a decision on Priority Review designation associated with the inclusion of VELA-TEEN adolescent data is expected by end of November 2026.
The launch US was expected in H2 2027.
