UNION therapeutics A/S announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral orismilast for the treatment of moderate to severe hidradenitis suppurativa (HS). HS is a chronic, progressive, inflammatory skin disease that usually develops after puberty as a result of inflamed hair follicles, most notably in the armpit and genital regions. The clinical hallmarks of the disease include very painful inflammatory nodules, boils or abscesses that typically open and release odorous inflammatory fluids. 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.