FDA Grants Fast Track Designation to Orismilast for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Fast Track designation to orismilast tablet for the treatment of moderate to severe atopic dermatitis.

Orismilast is a selective next generation phosphodiesterase-4 (PDE4) inhibitor with broad anti-inflammatory properties. The Company believes orismilast has the potential to inhibit many autoimmune pathways involved in dermatologic diseases. Both an oral formulation and a topical formulation will be investigated.

The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments. Based on proof-of-concept data, orismilast has the potential to be an effective treatment for atopic dermatitis with fewer gastrointestinal side effects.  

“We believe that oral orismilast holds great promise and has the potential to become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis without the safety issues associated with oral corticosteroids,” said Kim Kjøller, CEO of UNION therapeutics.

The Company is also evaluating the safety and efficacy of orismilast tablet for the treatment of mild, moderate, or severe hidradenitis suppurativa in adults (ClinicalTrials.gov Identifier: NCT04982432).

Reference

UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis. News release. UNION therapeutics. Accessed November 4, 2021. https://www.prnewswire.com/news-releases/union-therapeutics-receives-fda-fast-track-designation-for-oral-orismilast-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-301416168.html.