Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema

Ionis Pharmaceuticals, Inc.

Overview

The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.

The Expanded Access Program (EAP) is intended to provide pre-approval access to donidalorsen for eligible patients with HAE who complete the ISIS 721744-CS3 clinical trial.

Study Type

EXPANDED_ACCESS

Conditions

Hereditary Angioedema

Interventions

DonidalorsenDRUG

Donidalorsen administered once monthly or every other month by subcutaneous (SC) injections in the abdomen, thigh, or upper arm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in the ISIS 721744-CS3 (Open-Label Extension \[OLE\] Study) who have completed 205 weeks of treatment. * Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity. Exclusion Criteria: * Any patient who is pregnant or plans to become pregnant. * Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.

Central Contacts

Ionis Pharmaceuticals Medical Information

CONTACT

1-833-644-6647 (833-MI-IONIS)MedInfo@ionisph.com

Data from ClinicalTrials.gov

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