The US Food and Drug Administration (FDA) has granted Fast Track designation to UNION therapeutics’ oral orismilast for the treatment of moderate to severe HS. The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address a significant unmet medical need.
A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate’s development plan as well as eligibility for rolling review and priority review.
In the coming interactions with FDA, UNION plans to discuss the most appropriate endpoints, target disease severity, and next steps in the clinical development of oral orismilast for the treatment of HS.
In September, the Danish Medicines Agency and Ethics Committee granted a Treatment Extension to the ongoing investigator-led study of oral orismilast (OSIRIS, Phase 2a)1) for the treatment of patients with mild to severe HS. With the Treatment Extension, patients who have completed the initial treatment period in the OSIRIS study may continue treatment with orismilast MR tablets for a period of 52 weeks.
Professor Gregor B. Jemec, PhD, MD, founding chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark said: “Hidradenitis suppurativa is an inflammatory systemic skin disease that seriously affects the life of patients. Despite the recent advances in the treatment of hidradenitis suppurativa, there is still a high unmet need in terms of safe and efficacious oral treatments. It is encouraging to see that FDA recognizes the potential of oral orismilast in hidradenitis suppurativa and grants it fast track designation.”
Kim Kjøller, Chief Executive Officer of UNION therapeutics, said: “We are very pleased to receive this Fast Track designation for oral orismilast in hidradenitis suppurativa (HS) and look forward to working closely with the FDA in the design of the clinical development program for oral orismilast. Our ambition is to provide an effective oral treatment for HS and in collaboration with dermatologists and patients develop relevant trial designs, addressing the true needs of patients living with HS.”