FDA Grants Fast Track Designation for Union’s Oral Orismilast for Moderate to Severe HS

Orismilast is a high-potency PDE4 inhibitor targeting the PDE4 subtypes linked to inflammation in many dermatological and immunological diseases.  

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).

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. 

"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," says Professor Gregor B. Jemec, PhD, MD, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark, in a news release.

"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,” adds Kim Kjøller, Chief Executive Officer of UNION therapeutics. “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."

Orismilast is a high-potency PDE4 inhibitor targeting the PDE4 subtypes linked to inflammation in many dermatological and immunological diseases.  

The FDA has cleared UNION's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan.