FDA Approvals, Highlights, and Summaries: Dermatology

February 27, 2020

Aklief (trifarotene)

Trifarotene is an agonist of retinoic acid receptors (RARs), with particular activity at the gamma subtype of RAR. Stimulation of RARs results in modulation of target genes that are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which trifarotene ameliorates acne is unknown. It is indicated for acne vulgaris for patients aged 9 years and older. Trifarotene is available as a cream.

Aklief prescribing information

Scenesse (afamelanotide)

Afamelanotide is a subcutaneously implantable alpha-melanocyte–stimulating hormone analog that increases melanin production in the skin independent of sunlight exposure or artificial light sources. It is indicated for prevention of photoxicity and anaphylactoid reactions in adults with erythropoietic protoporphyria (EPP).

EPP is a rare disorder caused by mutations leading to impaired activity of ferrochelatase, an enzyme involved in heme production; decreased ferrochelatase activity leads to protoporphyrin IX (PPIX) accumulation in the body; light reaching the skin can react with PPIX, causing intense skin pain and skin changes (eg, redness, thickening). Afamelanotide, a melanocortin-1 receptor (MC1-R) agonist, increases production of eumelanin (the most common type of melanin) in the skin independent of exposure to sunlight or artificial light sources. It is indicated to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP.

US approval was based on 2 multicenter, randomized, double-blind, placebo-controlled trials in patients residing in the European Union (n=74) and the United States (n=94). Patients were randomly assigned, in a 1:1 ratio, to receive a subcutaneous implant containing either afamelanotide or placebo every 60 days (a total of 5 implants in the European Union study and 3 in the US study). The type and duration of sun exposure, number and severity of phototoxic reactions, and adverse events were recorded over the respective 180-day and 270-day study periods. In the US study, the duration of pain-free time after 6 months was longer in the afamelanotide group (median, 69.4 hr vs 40.8 hr in the placebo group; P=.04). In the European Union study, the duration of pain-free time after 9 months was also longer in the afamelanotide group than in the placebo group (median, 6 hr vs 0.8 hr; P=.005), and the number of phototoxic reactions was lower in the afamelanotide group (77 vs 146, P=.04).

N Engl J Med. 2015 Jul 2;373(1):48-59 .

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.

Dermatol Surg. 2019 Nov;45(11):1381-1393 .

Aesthet Surg J. 2019 Apr 5

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 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).

Lancet. 2018 Aug 25;392(10148):650-661

Additional 2019 Dermatology approvals

Amzeeq (minocycline topical) is the first topical minocycline product for treatment of acne vulgaris in adults and children aged 9 years or older.

Arazlo (tazarotene) lotion is approved for acne vulgaris in adults and children aged 9 years or older.

Otezla (apremilast) is approved for adults with oral ulcers associated with Behcet disease.

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

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


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