News|Articles|December 3, 2025

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Name: Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course
Uploaded: 2025-12-03T23:00:01.997Z
Duration: 4 min 30 s
Description: Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Author(s)Daniel Soteres, MD, PhD, Raffi Tachdjian, MD, MPH, Michael Manning, MD

Fact checked by: Chelsie Derman, Patrick Campbell

Recent advancements in HAE treatments offer hope, but experts stress the need for more pediatric options and diverse therapies.

A disease often associated with delayed diagnosis and treatment, hereditary angioedema (HAE) has drawn significant attention in 2025. The US Food & Drug Administration (FDA) approved 3 HAE treatments in just 3 months: garadacimab-gxii (Andembry) in June, sebetralstat (Ekterly) in July, and donidalorsen (Dawnzera) in August.^1,2,3