Vilobelimab Fast Tracked for Ulcerative Pyoderma Gangrenosum
Vilobelimab is a first-in-class anti-human complement factor C5a monoclonal antibody.
Diagnosis & Disease Information
Olumiant Approved for Severe Alopecia Areata
The approval was based on data from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 trials, which included adults with severe alopecia areata.
Dupixent Approved for Atopic Dermatitis in Younger Pediatric Patients
The approval was based on data from a phase 3 study that evaluated Dupixent added to low potency topical corticosteroids in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis.
Lebrikizumab-Associated Improvements in Skin Clearance Maintained in Atopic Dermatitis Trials
The ADvocate 1 and ADvocate 2 trials evaluated lebrikizumab as monotherapy in patients aged 12 years and older weighing at least 40kg with moderate to severe atopic dermatitis.
Epsolay Cream Now Available for Rosacea
Epsolay is a topical cream that utilizes a patented technology process to encapsulate benzoyl peroxide 5% within silica-based microcapsules.
Dupilumab Gets Priority Review for Prurigo Nodularis
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
Efficacy Response Maintained With Deucravacitinib in Plaque Psoriasis Trial
The POETYK PSO-LTE trial evaluated deucravacitinib 6mg orally once daily in 1221 adults with moderate to severe plaque psoriasis.
Topical Rosacea Treatment Epsolay Gets FDA Approval
Epsolay is a topical cream that utilizes a patented technology process to encapsulate benzoyl peroxide 5% within silica-based microcapsules.
FDA Extends Review Period for Ruxolitinib Cream for Vitiligo
The sNDA submission included data from the phase 3 TRuE-V clinical trial program.
Trial Evaluating Dupilumab in Difficult-to-Treat Chronic Spontaneous Urticaria Stopped
Study B of the CUPID trial evaluated dupilumab in 83 patients with CSU aged 12 to 80 years who remained symptomatic despite standard of care treatment and were intolerant or incomplete responders to omalizumab.
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