MPR YIR Derm 2018 Archives - MPR

MPR YIR Derm 2018

Novel Treatment for Primary Axillary Hyperhidrosis Gets FDA Approval

The approval was supported by Phase 3 data from the ATMOS-1 and ATMOS-2 trials which evaluated the absolute change from baseline in sweat production after treatment with Qbrexza, and the proportion of patients who achieved ≥4-point improvement from baseline in their sweating severity (as measured by the Axillary Sweating Daily Diary [ASDD]).

Taltz Label Updated to Include Data on Psoriasis Affecting Genital Area

The approval was based on data from a randomized, placebo-controlled trial that included 149 adults with plaque psoriasis who had a minimum body surface area (BSA) involvement of 1%, a static Physician Global Assessment (sPGA) score of ≥3 (moderate psoriasis), a sPGA of Genitalia score of ≥3 (moderate psoriasis involving the genital area), who failed to respond to or were intolerant of at least one topical therapy used for the treatment of psoriasis affecting the genital area, and who were candidates for phototherapy and/or systemic therapy.