Cantharidin topical solution 0.7%
Trade Name: Ycanth™
Company: Verrica Pharmaceuticals
Approval Dates/Comments: The US FDA approved cantharidin topical solution in July 2023 for the treatment of molluscum contagiosum (molluscum) in patients ≥2 years of age. This is the first FDA-approved therapy for molluscum. Cantharidin’s mechanism of action is via activation of neutral serine proteases that cause degeneration of the desmosomal plaque, leading to detachment of tonofilaments from desmosomes, resulting in acantholysis and intraepidermal blistering, and nonspecific lysis of the skin. Treatment is administered to patients by health care providers as a single application directly to each lesion and removed with soap and water after 24 hours. Treatments can be reapplied every 3 weeks as needed. Regulatory approval is based on the results of the CAMP-1 and CAMP-2 clinical trials. In CAMP-1, 46% of patients treated with cantharidin achieved complete clearance of molluscum lesions vs. 18% in the vehicle group; in CAMP-2, 54% of patients treated with canthardin achieved complete clearance vs. 13% in the vehicle group. The most common (incidence ≥1%) side effects included local, application site skin reactions (i.e., vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema and erosion).
Trade Name: Litfulo™
Approval Dates/Comments: In June 2023, the FDA approved ritlecitinib, the first and only, once-daily oral treatment, for patients ≥12 years of age with severe alopecia areata (AA). Ritlecitinib is a small molecule drug that selectively inhibits Janus kinase 3 and tyrosine kinase, blocking the signaling of molecules and immune cells implicated in AA. Regulatory approval is based on the results of the ALLEGRO Phase 2b/3 trial (NCT03732807), which included 718 individuals with ≥50% scalp hair loss measured by the Severity of Alopecia Tool. The findings showed that 23% of patients treated with ritlecitinib experienced ≥80% scalp hair coverage after 6 months vs. 1.6% of patients receiving placebo. The most common adverse events through 24 weeks of treatment included headache, diarrhea, acne, rash and urticaria.
Clascoterone cream 1%
Trade Name: Winlevi®
Company: Sun Pharma
Approval Dates/Comments: Health Canada approved clascoterone cream 1% in June 2023 as the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients ≥12 years of age. Clascoterone works by targeting the hormonal component of acne. The proposed mechanism of action is that clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles, resulting in reduced sebum production and decreased inflammation.
Isotretinoin capsules micronized formulation
Trade Name: Absorica LD®
Company: Sun Pharma
Approval Dates/Comments: In June 2023, Health Canada approved the only micronized formulation of isotretinoin for the treatment of severe acne in patients ≥12 years of age. Therapy is indicated for severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne, and is taken as whole capsules either as a single dose or in two divided doses. Absorica LD® is the only micronized formulation, which provides enhanced bioavailability resulting in comparable rate and extent of isotretinoin exposure with or without food.