Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

Inclusion Criteria:

• • Aged >= 12 years at the time of providing written informed consent / assent.

• • Have a history of response to on-demand HAE treatment for the treatment of acuteHAE attacks.

• • Documented laboratory diagnosis in medical records of C1-esterase inhibitorhereditary angioedema (HAE-C1INH) type 1 or type 2:

• ◦ Documented clinical history consistent with HAE (subcutaneous or mucosal,nonpruritic swelling episodes without accompanying urticaria),

• ◦ C1-esterase inhibitor (C1INH) antigen concentration or functional activity lessthan (<) 50% of normal as documented in the participant's medical record, or

• ◦ C4-antigen concentration below the lower limit of the reference range asdocumented in the participant's medical record.

• For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous ormucosal, nonpruritic swelling episodes without accompanying urticaria); anHAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg,or deletion of 72 base pairs [c.971_1018 + 24del72], or duplication of 18 base pairs [c.892-909dup]), as documented in the participant's medical record, OR anHAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutationLys330Glu), as documented in the participant's medical record; C1INH antigenconcentration or functional activity 70 to 120% of the normal level, as documentedin the participant's medical record.

• Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAEand be on a stable (consistent) dose / regimen of such medication for at least 3months prior to Screening.

Exclusion Criteria:

• • Concomitant diagnosis of another form of angioedema, such as idiopathic oracquired angioedema or recurrent angioedema associated with urticaria.

• • Use of androgens, antifibrinolytics, or investigational products (other thangaradacimab) for routine prophylaxis against HAE attacks.

• • Known or suspected hypersensitivity to monoclonal antibody therapy orhypersensitivity to the active substance (garadacimab) or to any of the excipients.