From groundbreaking therapies to first-in-class drugs, 2022 has been an exciting year for dermatology. Here is a brief recap of some of the most notable advances and U.S. Food and Drug Administration (FDA) approvals from last year.
January 14, 2022, saw the approval of AbbVie’s Rinvoq (upadacitinib) for the treatment of moderate-to-severe atopic dermatitis among patients aged 12 years and older. The approval of this selective JAK inhibitor was supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis, with more than 2,500 patients evaluated across three studies. Rinvoq, which has been approved in two dose strengths (15 mg and 30 mg), demonstrated significant improvement in itch as early as week one.
January also saw the approval of Cibinqo, an oral, once-daily JAK inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis. Pfizer’s Cibinqo was approved based on the results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. Cibinqo demonstrated a consistent safety profile and improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks. Cibinqo is approved at the recommended doses of 100 mg and 200 mg.
On March 25, 2022, Cutera announced the FDA approval of AviClear, a laser treatment that offers a safe, prescription-free solution for acne. In addition to reducing existing acne, clinical trials revealed that future breakout episodes were shorter, less intense, and more infrequent following the AviClear procedure. It is a safe, prescription-free solution for acne.
In May, Dermavant Sciences announced that the FDA had approved Vtama (tapinarof) 1% cream for the treatment of plaque psoriasis in adults. Vtama, an aryl hydrocarbon receptor agonist, became the first and only FDA-approved steroid-free topical medication in its class. Vtama cream is safe and efficient and can also be used on all body areas, including sensitive locations on the body.
On June 7, 2022, Regeneron Pharmaceuticals and Sanofi announced that the FDA had extended the approval of Dupixent (dupilumab) to include children aged 6 months to 5 years with moderate to severe atopic dermatitis. It became the first biologic medicine for children in that age group. The approval was based on data from a Phase 3 trial which demonstrated Dupixent met all primary and all secondary endpoints.
Later in June, the FDA also approved Lilly and Incyte’s Olumiant (baricitinib) for the treatment of adult patients with severe alopecia areata. The once-daily oral Janus kinase (JAK) inhibitor was previously approved for rheumatoid arthritis and atopic dermatitis. In two trials, patients received either a placebo, 2mg of Olumiant, or 4mg of Olumiant every day. Results showed that patients taking Olumiant experienced at least 80% of scalp hair coverage by week 36.
Brett A. King, MD, PhD, associate professor of dermatology at Yale University School of Medicine, lead investigator of the BRAVE-AA program, and LiVDerm Advisory Board Member, is seen as a pioneer in the use of JAK inhibitors in cutaneous diseases. He had this to say about the approval of Lilly and Incyte’s Olumiant.
On July 18, 2022, Incyte announced the FDA’s approval of Opzelura (ruxolitinib) cream for vitiligo. This 1.5% cream for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, was the first and only FDA-approved product for repigmentation in nonsegmental vitiligo. FDA approval was based on data from the pivotal Phase 3 TRuE-V clinical trial program, which saw significant improvements in Vitiligo Area Scoring Index scores.
On July 27, 2022, Cytrellis announced the FDA had cleared their first proprietary product, the ellacor system, using micro-coring technology, for the treatment of moderate-to-severe wrinkles in the mid to lower face. The ellacor system is a minimally-invasive device that safely and effectively removes micro-sized portions of excess skin without surgery, thermal energy, or evidence of scarring.
Arcutis Biotherapeutics announced on July 29, 2022, that Zoryve (roflumilast cream 0.3%), had been given FDA approval for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. A nonsteroid, phosphodiesterase-4 inhibitor, Zoryve, is a once-daily topical treatment providing rapid clearance of plaques and reduction of itch in all affected areas of the body.
In September 2022, Bristol Myers Squibb’s Sotyktu (deucravacitinib) was approved by the FDA for the treatment of moderate-to-severe plaque psoriasis. Sotyktu is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor with a well-demonstrated safety and tolerability profile based on the POETYK PSO clinical trials.
In November, the FDA cleared Accure Acne’s Accure Laser System to treat mild-to-severe inflammatory acne vulgaris. The Accure Laser System builds upon the unique selectivity of the 1726nm laser wavelength, targeting sebaceous glands. It signals a significant breakthrough in acne treatment.
Based on the significant advancements of the previous year, we can be sure 2023 will be filled with even more remarkable breakthroughs.