HAE, Hereditary Angioedema, Prophylaxis
Conditions
Keywords
Berotralstat, BCX7353, Hereditary Angioedema, HAE
Brief summary
This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.
Detailed description
Physicians may request access to berotralstat for eligible participants with unmet medical need Physicians can send email inquiries to access.us@inceptua.com or call 1-888-225-8677 Patients who may be interested should contact their physician about participation Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available
Interventions
DRUGBerotralstat
One 150mg capsule administered orally once daily
Sponsors
BioCryst Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this program: 1. At least 12 years of age 2. Able to provide written, informed consent or assent 3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial 4. Females must use acceptable effective contraception
Exclusion criteria
Patients must meet none of the below
Outcome results
None listed