FDA Approvals, Highlights, and Summaries: Dermatology

February 24, 2021

Xeglyze (abametapir)

Abametapir, a metalloproteinase inhibitor and topical pediculicide, is indicated for head lice infestation in adults and children aged 6 months and older.

Approval was supported in part by a double-blind, phase 2 trial in 50 patients with active head lice infestation who were randomized to receive a single treatment of abametapir lotion or vehicle (control) applied to scalp and hair for 10 minutes. Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched, compared with 64% for vehicle. Accounting for pretreatment hatch rates, the absolute reduction in egg hatching was 92.9% for abametapir versus 42.3% for vehicle (P <.0001). ( Glob Pediatr Health. February 22, 2019;6)

Two studies (n=704) showed that 81.5% of abametapir-treated individuals were free of lice 2 weeks after a single application, compared with 49.1% treated with vehicle (P <.001). ( Pediatr Dermatol. 2018;35(5):616-621)

Klisyri (tirbanibulin topical)

Tirbanibulin topical is indicated for actinic keratosis of the face or scalp. It is a microtubule inhibitor, although the mechanism by which it is effective for actinic dermatosis is unknown.

Approval was based on two phase 3 clinical trials (AK003 and AK004) that evaluated the safety and efficacy of tirbanibulin topical in adults (N=702) with facial or scalp actinic keratosis. The tirbanibulin-treated group achieved a higher percentage of complete clearance of actinic keratosis at Day 57 (AK003, 44% vs 5%; AK004, 54% vs 13%) and partial clearance compared with placebo in both trials (AK003, 68% vs 16%; AK004, 76% vs 20%). (Klisyri prescribing information)

Winlevi (clascoterone topical)

Clascoterone topical is an androgen-receptor inhibitor indicated for acne vulgaris in patients aged 12 years and older. The exact mechanism of action by which it clascoterone is effective for acne is unknown. Laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles.

Approval of clascoterone topical was supported by 2 phase 3 randomized trials including 1,440 patients. At week 12, treatment success rates showed statistically significant improvement for patients receiving clascoterone (18.4% and 20.3%) compared with the vehicle alone (9% and 6.5%). ( JAMA Dermatol, June 1, 2020;165(6):621-30)

Other notable dermatologic approvals

Vectical (calcitriol topical) - Indication for plaque psoriasis expanded to include children aged 2 years and older (previously approved for adults)

Stelara (ustekinumab) - Indication for plaque psoriasis expanded to include children aged 6 years and older (previously approved for aged ≥12 years)

Ultravate lotion (halobetasol topical) - Indication expanded to include adolescents aged 12 years and older

Zilxi (minocycline topical) - New 1.5% product for rosacea

Qwo (collagenase clostridium histolyticum) - New indication for moderate-to-severe cellulite of the buttocks in women

Dupixent (dupilumab) - Indicated for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable in children aged 6 years or older

Jublia (efinaconazole) - Indication for onychomycosis expanded to include children as young as 6 years

Taltz (ixekizumab) - Indication for plaque psoriasis expanded to include children aged 6 years or older

Eucrisa (crisaborole topical) - Indicated for mild-to-moderate atopic dermatitis in infants and children aged 3 months or older


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