Definitions: Dystrophic EB (“DEB”); Junctional EB (‘‘JEB’’); Recessive Dystrophic EB (‘‘RDEB’’)
• Upcoming clinical milestones are subject to the impact of COVID-19 on our business.
(1) Juxtapid has a Boxed Warning for the risk of hepatoxicity.
(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’’) post-approval commitments.
(3) An investigator-led open-label Phase 2 trial studying lomitapide in patients with FCS has completed and we announced encouraging topline data on efficacy and safety on March 30 2021.
(4) Myalept has a Boxed Warning for the risk of anti-metreleptin neutralising activity and lymphoma.
(5) 505(b)(2) pathway Phase 2 not required, Phase 3 planned in 2022.
(6) Oleogel-S10 was approved in 2016 by the EMA for the treatment of partial thickness wounds in adults but has not been commercially launched.
(7) We have not yet commenced any clinical trials for radiation-induced dermatitis. This planned 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.
AMYT/ALL/004 August 2021