FDA Drug Approvals, Dermatology — 2019 Midyear Review

Mary L Windle, PharmD


August 05, 2019

Jeuveau (prabotulinumtoxinA-xvfs)

PrabotulinumtoxinA, an acetylcholine-release inhibitor and neuromuscular blocker, is indicated for temporary improvement in the appearance of moderate-to-severe glabellar facial lines associated with corrugator and/or procerus muscle activity in adults.

Approval was based on 2 randomized, multicenter, double-blind, placebo-controlled trials of identical design (N=654). At day 30, 67-71% of patients treated with prabotulinumtoxinA achieved grade 2 or higher improvement for the glabellar line scale from baseline at maximum frown, compared with 1% of those treated with placebo.[1,2]

Skyrizi (risankizumab)

Risankizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of the human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. It was approved in April 2019 for treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Approval was based on the UltlMMa-1 and UltlMMa-2 replicate phase 3, randomized, double-blind, placebo-controlled and active comparator–controlled international trials (N=997). Coprimary endpoints were proportions of patients achieving a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16 (nonresponder imputation). Risankizumab showed superior efficacy to both placebo and ustekinumab in the treatment of moderate-to-severe plaque psoriasis.

At week 16 of each study, PASI 90 was achieved by 74.8-75.3% patients receiving risankizumab, compared with 2-4.9% receiving placebo and 42-47.5% receiving ustekinumab (P <.0001 vs placebo and ustekinumab). Results from each trial for sPGA 0 or 1 at week 16 was achieved by 83.7-87.8% patients receiving risankizumab, compared with 5.1-7.8% receiving placebo and 61.6-63% receiving ustekinumab (P <.0001 vs placebo and ustekinumab).[3]

Other notable dermatology approvals

Dupixent (dupilumab) indication for atopic dermatitis was expanded to include adolescents aged 12 years or older.

Duobrii (halobetasol/tazarotene) is a new topical combination for adults with plaque psoriasis.


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