Donidalorsen Treatment in Children With Hereditary Angioedema

Key Inclusion Criteria:

1. Must be between the ages of 2 and less than 12 years, inclusive, at the time ofinformed consent and, as applicable, assent.

2. Must weigh at least 9 kg at the time of informed consent and, as applicable, assent.

3. Documented diagnosis of HAE-1/HAE-2 based upon both of the following:

4. Documented clinical history consistent with HAE (SC or mucosal, non-pruriticswelling episodes without accompanying urticaria).

5. Diagnostic testing results that confirm HAE-1/HAE-2: C1-inhibitor (C1-INH)functional level <50% normal level AND complement factor C4 level below thelower limit of normal (LLN); OR a known pathogenic mutation in the SERPING1gene.

Key Exclusion Criteria:

1. Must not have any screening laboratory abnormalities or any other clinicallysignificant abnormalities during screening that would render a participantunsuitable for inclusion.

2. Must not have been treated with another investigational drug, biological agent, ordevice within 1 month of Screening, or 5 half-lives of investigational agent,whichever is longer.

3. Concurrent diagnosis of any other type of recurrent angioedema, including idiopathicangioedema or HAE with normal C1-INH (HAE-nC1-INH or Type III).

Note: Other protocol-specified inclusion/exclusion criteria may apply.