Atopic dermatitis is a chronic inflammatory skin disease primarily characterized by recurrent eczematous skin lesions and intense itching. Atopic dermatitis can have serious psychosocial consequences for patients and their relatives. During the onset of the disease, about 80% of patients will experience sleep disorders, which may also affect the sleep quality of their family members. The disease can affect a patient's mood, and in severe cases can lead to depression.
On November 4, 2021, UNION therapeutics A/S (UNION) announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to oral Orismilast for the treatment of patients with moderate to severe atopic dermatitis (AD).
(Source: Internet)
Dr. Jonathan Silverberg said: "Atopic dermatitis is one of the most common chronic skin diseases in the world. Although some progress has been made in the treatment of atopic dermatitis in recent years, there is still a large unmet need for safe and effective oral treatments. It is encouraging that the FDA recognizes the potential of Orismilast to treat atopic dermatitis and granted it Fast Track designation, which will accelerate Orismilast's marketing process."
Orismilast is a potent and selective next-generation PDE4 inhibitor. PDE4 inhibition plays an important role in the inflammatory cascade and therefore has the potential to inhibit many autoimmune pathways associated with skin diseases. The safety and tolerability of PDE4 inhibitors are well known, and two oral PDE4 inhibitors and one topical PDE4 inhibitor have been approved for marketing.
Orismilast improves anti-inflammatory potency while minimizing gastrointestinal side effects. In addition, the effectiveness of Orismilast has been demonstrated in patients with psoriasis and atopic dermatitis.
UNION Therapeutics also has two product candidates in the clinical stage: UNI50001, an oral PDE4 inhibitor currently being studied for the treatment of psoriasis, atopic dermatitis and Henoch-Schonlein purpura (HS); and UNI50002, a non-steroidal topical PDE4 inhibitor currently being studied for the treatment of AD.
References:
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
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