Cibinqo Approved for Adolescents With Moderate to Severe Atopic Dermatitis
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor.
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.
Results showed a significantly greater proportion of patients treated with tapinarof cream achieved vIGA-AD success compared with vehicle cream.
A 72-year-old man is referred for evaluation of a rash involving his perianal region. Can you make the correct diagnosis?
The application is supported by data from the phase 3 TRuE-V clinical trial program.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
The INTEGUMENT-2 trial included patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area.
The BE HEARD I and BE HEARD II studies included more than 1000 adults with moderate to severe hidradenitis suppurativa.