Expanded Access Policy

Consistent with LEO Pharma’s mission to help people achieve healthy skin, LEO Pharma is dedicated to developing new therapies that have a positive impact on patient health. 

LEO Pharma works in alignment with health authorities to conduct clinical trials that address unmet medical needs and make new therapies available to patients as quickly as possible.  

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to delgocitinib cream, an investigational topical product under clinical development for the treatment of moderate to severe chronic hand eczema (CHE).   

At this time, LEO Pharma has not established an Expanded Access Program that allows patients access to delgocitinib outside of clinical trials or prior to regulatory approval. LEO Pharma believes participation in clinical trials is the most appropriate way to access delgocitinib at this stage of development. Information about LEO Pharma’s clinical trials, including eligibility and locations, is available at clinicaltrials.gov

LEO Pharma recognizes the importance of Expanded Access Programs and may update this policy based on data from ongoing drug development programs and future clinical trials.   

If you are a patient or caregiver with questions about access to delgocitinib clinical trials, the licensed physician overseeing your care should contact LEO Pharma’s Medical Information department at globalmedical_info_dk@leo-pharma.com. LEO Pharma plans to acknowledge the receipt of specific inquiries within five (5) business days.  

LEO Pharma Expanded Access Policy (PDF version)