Definitions: Dystrophic EB (“DEB”); Junctional EB (‘‘JEB’’)
* Upcoming clinical milestones are subject to the impact of COVID-19 on our business.
(1) Global Phase 3 study to support US label expansion for metreleptin in the treatment of partial lipodystrophy (PL).
(2) We are conducting a Phase 3 study of homozygous familial hypercholesterolemia (“HoFH”) in children and adolescents in Europe, the Middle East and Africa (“EMEA”) as part of our European Medicines Agency (‘‘EMA’’) pediatric investigation plan (PIP) commitment.
(3) 505(b)(2) pathway Phase 2 not required, Phase 3 initiation anticipated in Q1 2023 for the treatment of carcinoid symptoms in NET.
(4) Oleogel-S10 was approved in 2016 by the EMA for the treatment of partial thickness wounds in adults but has not been commercially launched. European Commission approval for the treatment of Dystrophic and Junctional EB, aged over 6 months, granted in June 2022.
(5) This radiation-induced dermatitis Phase 2 trial is an investigator-initiated study.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Reporting forms and information can be found on the MHRA Yellow Card reporting site https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store
Contact Medical Information for medical information requests, to report adverse events and product complaints by visiting Amryt’s Medical Information Enquiries.