FDA delivers three new HAE drugs after four-year drought

The American medicines regulator has ended a barren stretch in hereditary angioedema with three approvals in 2025, according to an analysis from GlobalData. The surge brings the total number of marketed innovator drugs for the rare disease in the USA to 11, adding new mechanisms and formats to the treatment arsenal.

HAE is a potentially life-threatening inherited disorder marked by sudden swelling in the extremities, abdomen, and throat. US Food and Drug Administration (FDA) approvals had been sparse before 2025, with only one each in 2017, 2018, and 2020, followed by four years without a green light. That drought broke this year with three distinct therapies.

Australian group CSL Behring led the charge with June approval of Andembry (garadacimab), the first drug targeting Coagulation Factor XII. Blocking this protein, which sparks the swelling cascade, is designed to stop attacks before they begin.