EAP for Deucrictibant Immediate-release
brief summary
This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as determined by their treating physician.
detailed description
The EAP is intended to address unmet medical needs not adequately addressed by currently available therapies and is not designed to replace clinical trials conducted to support regulatory assessment and approval of the investigational product. The program will continue beyond the commercial availability of deucrictibant IR, upon regulatory approval, for up to approximately 6 months to ensure continuity of treatment for participants for whom ongoing therapy is considered appropriate. Participants will self-administer 1 capsule orally at the onset of an HAE attack. If response is inadequate or symptoms worsen or recur, a second capsule may be taken at least 4 hours after the initial dose. Capsule(s) may be taken with or without food.
official title
Expanded Access for Deucrictibant IR Capsule