FDA fast track oral treatment of dermatitis
pharmafile | November 4, 2021 | News story | Business Services |
UNION therapeutics have received a Fast Track designation from the FDA for their oral orismilast for the treatment of moderate to severe atopic dermatitis. The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need.
Atopic dermatitis is one of the most common chronic inflammatory skin diseases in the US, with an estimated 30% of the population, largely children and adolescents, affected. People suffering may also be particularly susceptible to bacterial, viral, and fungal skin infections. It affects approximately 3% of the adult population worldwide and is the most common skin disease among children. During disease flares, approximately 80% of patients may experience disturbed sleep.
Kim Kjøller, CEO of UNION said: “We are very pleased to receive this Fast Track designation for oral orismilast and look forward to working closely with the FDA. 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.”
Orismilast is a potent next generation PDE4 inhibitor. PDE4 inhibition works high in the inflammation cascade and as such has the potential to inhibit many autoimmune pathways involved in dermatologic diseases. UNION Therapeutics is a clinical stage, pharmaceutical company focusing on immunology and infectious diseases.
UNION Therapeutics has two product candidates with orismilast in its clinical stage pipeline: UNI50002, an oral PDE4 inhibitor currently investigated for the treatment of psoriasis, AD and HS, and UNI50002, a non-steroidal topical PDE4 inhibitor currently investigated for the treatment of AD.
Ana Ovey
