Benzoyl peroxide 5% cream

Trade Name: Epsolay®
Company: Sol-Gel/Galderma

Approval Dates/Comments: In April 2022, the US FDA approved this proprietary cream formulation of benzoyl peroxide (BP), 5%, for the treatment of inflammatory lesions of rosacea in adults. The BP in Epsolay® is encapsulated within silica-based patented microcapsules. The silica-based shell slowly releases BP over time to provide a favorable efficacy and safety profile. Approval is supported by positive data from two identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay® vs. vehicle. With Epsolay® treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials vs. 38-46% with the vehicle. Nearly 50% of subjects were ‘clear’ or ‘almost clear’ at 12 weeks vs. 38-46% with placebo.

Isotretinoin ointment

Trade Name: TMB-001
Company: Timber Pharmaceuticals

Approval Dates/Comments: The FDA granted Breakthrough Therapy designation in May 2022 to TMB-001, topical isotretinoin formulated using the patented IPEG™ delivery system, for the treatment of congenital ichthyosis (CI). In the Phase 2b CONTROL study, therapy with TMB-001 demonstrated a clinically meaningful reduction in targeted and overall severity of CI along with a favorable safety profile. The pivotal Phase 3 ASCEND clinical trial is underway.

Tapinarof 1% cream

Trade Name: Vtama™
Company: Dermavant Sciences

Approval Dates/Comments: In May 2022, the FDA approved tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This is the first and only FDA-approved steroid-free topical medication in its class.

Baricitinib tablets

Trade Name: Olumiant®
Company: Eli Lilly and Company

Approval Dates/Comments: In June 2022, the FDA approved once-daily oral baricitinib, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA). Baricitinib is a small-molecule, selective inhibitor of Janus kinase (JAK) 1 and 2, available as 1 mg, 2 mg and 4 mg tablets. Regulatory approval is based on favorable results from the Phase 3 BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 adults with severe AA. At 36 weeks for both studies, 17-22% of patients taking baricitinib 2 mg/day and 32-35% of patients on baricitinib 4 mg/day achieved ≥80% scalp hair coverage, vs. 3-5% on placebo. Additionally, 11-13% of patients on 2 mg/day and 24-26% on 4 mg/day experienced at least 90% hair coverage, vs. 1-4% on placebo. For patients with substantial eyebrow and eyelash hair loss, those taking the 4 mg dose experienced improvement at week 36. In line with the drug class, baricitinib comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

Dupilumab for SC injection

Trade Name: Dupixent®
Company: Regeneron/Sanofi

Approval Dates/Comments: In June 2022, the FDA approved dupilumab for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab was granted Priority Review status for this indication, with the final decision based on positive results from the Phase 3 trial that investigated the drug’s efficacy and safety when combined with low-potency topical corticosteroids (TCS) vs. TCS alone. Findings demonstrated that dupilumab achieved the primary endpoint for the 6 months to 5 years age group, with 28% achieving clear or almost clear skin vs. 4% on placebo. Improvements in overall disease severity was 53% in the dupilumab plus TCS group vs. 11% in the placebo group. Also, 48% achieved clinically meaningful reduction in pruritus vs. 9% with placebo.

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