Conclusions
1 evidence topic · 4 sources
Summary
HAELO provides evidence of reduced attack frequency compared with placebo. The reported median follow-up of 7.5 months does not establish lifetime durability or exclude uncommon delayed adverse effects. Cross-trial comparisons do not establish comparative effectiveness against active prophylactic treatments. The FDA accepted the BLA for Priority Review with a target action date of March 10, 2027; application acceptance is not marketing approval.