Arcutis Biotherapeutics announced submission of the sNDA today, citing the the supporting positive data from the phase 3 INTEGUMENT-PED and INTEGUMENT-OLE trials.
Nemolizumab is the first approved monoclonal antibody that targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.
Approval for the topical nonsteroidal therapy, based on data from the phase 3 ADORING clinical trial program, helps fill a gap in current offerings for atopic dermatitis.
The new nonsteroidal topical treatments for atopic dermatitis are targeted and modify the disease process, explains thought leader Shahriari in this year's video series.
Upadacitinib (15 and 30 mg) was evaluated in adolescents with moderate to severe AD aged 12 to 17 years, with and without topical corticosteroids.
Your daily dose of the clinical news you may have missed.
Up to 80% of atopic dermatitis is managed in primary care but some patients will need a higher level of care. Dr Mona Shahriari discusses factors that point to referral.
They are a Janus kinase (JAK)1/JAK2 inhibitor, a phosphodiesterase-4 inhibitor, and an investigational aryl hydrocarbon receptor agonist. Learn more about each.
The standard 3-month extension is required by the FDA to review what it considered a "major amendment" to the Organon sNDA, ie, new data from ADORING 3.
There are 3 classes of nonsteroidal topical therapies for atopic dermatitis that target the specific underlying pathophysiology of the skin disease. Shahriari provides a primer.