The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.
Male or female patients 2 to 11 years of age.
Parent or LAR provides signed informed consent and patient provides assent (when applicable).
Confirmed diagnosis of HAE.
Confirmed diagnosis of HAE with nC1-INH or acquired angioedema
Patient weighs <9.5 kg
Patient participated in the KVD900-303 trial and withdrew prior to trial completion per the protocol or trial closure
Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.