Catch up on coverage of FDA-approved drugs in 2023.
2023 had no shortage of dermatology drug approvals, and 2024 is shaping up to be just the same. To keep up with approvals from the year, review our comprehensive recap below.
February 10, 2023: Abrocitinib Approved for Adolescents With Atopic Dermatitis
The FDA approved a supplemental new drug application to expand the use of abrocitinib (Cibinqo, Pfizer) for adolescents with moderate to severe atopic dermatitis (AD) when other systemic drug products are not adequate or advisable. Abrocitinib is an oral Janus kinase (JAK) 1 inhibitor, which is hypothesized to modulate multiple cytokines involved in the pathophysiology of AD, including interleukins (IL)-4, IL-13.
March 21, 2023: FDA Approves Adalimumab-Adaz High-Concentration Formulation
As the year of adalimumab (Humira; AbbVie) biosimilars continues, the FDA approved a citrate-free high-concentration (HCF) formulation of adalimumab-adaz(Hyrimoz; Sandoz & Novartis). Sandoz, a division of Novartis, plans to launch adalimumab-adazHCF on July 1, 2023.
The FDA approved Incyte’s retifanlimab-dlwr(Zynyz) for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. The FDA approved Incyte’s Biologics License Application for MCC treatment with retifanlimab-dlwr, a humanized monoclonal antibody targeting programmed death receptor-1, under accelerated approval based on tumor response rate and duration of response. According to Incyte, continued approval of retifanlimab-dlwrfor MCC may be “contingent on verification and description of clinical benefit in confirmatory trials.”
The FDA approved Skinviveby Juvederm, the first hyaluronic acid intradermal microdroplet injection, for improving skin smoothness in adult patients ages 21 and older. Allergan Aesthetics, an AbbVie company, announced the approval in a press release. At this time, Skinvive is the first and only treatment of its kind. The injectable gel containslocal anesthetic lidocaine and works to improve skin quality in patients’ cheeks through increasing hydration and smoothing the skin.
The FDA approved Krystal Biotech’s beremagene geperpavec (B-VEC; Vyjuvek) for the treatment of dystrophic epidermolysis bullosa (DEB). The approval is based on positive data from 2 placebo-controlled clinical trials, GEM 3 (NCT04491604) and GEM1/2 (NCT03536143). B-VEC was granted priority review designation in August 2022, as DEB is a rare and severe skin disease that does not have any other available treatment options. B-VEC is a non-invasive, topical, redosable gene therapy created to administer two copies of the COL7A1 gene when directly applied to DEB wounds.
May 22, 2023: FDA Approves Cyltezo Autoinjector Pen
The FDA approved the Cyltezo(adalimumab-adbm) Pen, a new autoinjector option from Boehringer Ingelheim. Adalimumab-adbm is an FDA-approved adalimumab (Humira) biosimilar that received interchangeability designation in October 2021. The 40 mg/0.8 mL pre-filled autoinjector pen will be available in 2, 4, and 6-pack options on July 1, 2023. With patients in mind, the design of the pen features a one-button, 3-step activation, with 100% drug visibility and a protected needle.
May 24, 2023: FDA Approves Yuflyma, the Ninth Adalimumab Biosimilar
Celltrion USA announced the FDA approval of Yuflyma (adalimumab-aaty), a citrate-free and high-concentration (100mg/mL) adalimumab (Humira) biosimilar. Yuflymais approved to treat 8 inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Yuflyma is the first high-concentration and citrate-free adalimumab biosimilar to gain European Union marketing authorization.
June 5, 2023: FDA Approves Galderma’s Restylane Eyelight
Galderma announced the FDA approval of Restylane Eyelight for the treatment of undereye hollows in adult patients over the age of 21. Restylane Eyelight is an undereye hyaluronic acid dermal filler and is the first and only US product formulated with NASHA Technology for volume loss. Restylane Eyelight will be available in clinics across the US in the next several months. Providers can learn more about Restylane’s availability and use at RestylaneUSA.com.
June 23, 2023: FDA Approves Ritlecitinib For Severe Alopecia Areata
Pfizer announced that the FDA approved ritlecitinib(Litfulo) for individuals aged 12 and over with severe alopecia areata. The once daily oral treatment is the first and only FDA-approved treatment for adolescents with severe alopecia areata. Ritlecitinib is a kinase inhibitor that inhibits Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases. The approved recommended dose for ritlecitinib is 50 mg a day.
Verrica Pharmaceutical’s VP-102 (Ycanth) was approved by the FDA for the treatment of molluscum contagiosum. VP-102 is a drug-device combination that contains a GMP–controlled formulation of cantharidin 0.7% w/v and gentian, a surgical dye meant to clearly mark treated lesions. VP-102 is the first FDA-approved drug for the treatment of molluscum contagiosum and offers dermatology providers and patients a precise in-office treatment. Providers have been eagerly awaiting the approval of VP-102, as molluscum contagiosum accounts for approximately 1% of all diagnosed skin conditions and is one of the 50 most common skin conditions.
Arcutis Biotherapeutics announced that the FDA approved its supplemental new drug application for the expanded indication of roflumilast cream 0.3% (ZORYVE) for the treatment of plaque psoriasis in children ages 6 to 11 years. The topical, once-daily- steroid-free cream can be applied in intertriginous areas and is designed to simplify plaque psoriasis management for pediatric patients, according to the announcement. Roflumilast is the only topical treatment that evaluated efficacy in intertriginous areas in pivotal clinical trials and the only therapy specifically indicated for use in these sensitive areas.
October 13, 2023: FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma
The FDA approved Bristol Myers Squibb’s nivolumab (Opdivo) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA’s approval is based on results from the pivotal phase 3 CheckMate -76K trial, where nivolumab demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo. Additionally, the safety profile of nivolumab was consistent with previously reported studies. Secondary end points of the phase 3 CheckMate -76K trial included overall survival, distant metastases-free survival, progression-free survival on next-line therapy, and safety endpoints.
October 18, 2023: FDA Approves Bimekizumab for Moderate to Severe Plaque Psoriasis
The FDA approved bimekizumab (BIMZELX, UCB) for the treatment of adults with moderate to severe plaque psoriasis who are also candidates for phototherapy or systemic therapy, making bimekizumab the first and only approved IL-17A and IL-17F inhibitor for this indication. The approval comes after positive phase 3 data from the BE READY, BE VIVID, and BE SURE trials evaluating the safety and efficacy of bimekizumab in 1,480 adults with moderate to severe plaque psoriasis. All studies met their primary and secondary endpoints.
October 31, 2023: FDA ApprovesSecukinumab for Hidradenitis Suppurativa
The FDA approved secukinumab (Cosentyx, Novartis) for the treatment of moderate to severe hidradenitis suppurativa (HS) and is currently the only anti-interleukin (IL)-17A inhibitor approved for the condition. The drug is already approved in the US for the treatment of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondylarthritis. In an analysis of the SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) phase 3 trials, which evaluated the safety and efficacy of the IL-17A therapy in adult patients with moderate to severe HS, investigators sought to identify the effects of secukinumab on the number of draining tunnels present in patients.
Ustekinumab-auub (Wezlana), an interchangeable biosimilar to ustekinumab (Stelara) was approved by the FDA for use in multiple inflammatory diseases, according to an FDA press release. Like its reference product, ustekinumab-auubis approved for use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, with active psoriatic arthritis, with moderately to severely active Crohn's disease, and with. Moderately to severely active ulcerative colitis.
October 20, 2023: IDP-126 Approved by FDA for Treatment of Acne
The FDA approved IDP-126 gel (CABTREO; clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%; Ortho Dermatologics) for the treatment of patients with acne. This makes IDP-126 gel the first FDA-approved fixed-dose triple-combination gel for patients with acne vulgaris. Earlier this year, Ortho Dermatologics announced its New Drug Application (NDA) filing had been accepted by the FDA. The NDA was based on positive data from 2 phase 3 controlled clinical trials that met absolute change from baseline in inflammatory lesion count.
December 15, 2023: FDA Approves Tralokinumab-ldrm for Atopic Dermatitis in Patients Ages 12-17
LEO Pharma Inc. announced the expansion of the approval of Adbry (tralokinumab-ldrm) by the FDA to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD). Adbry is now recognized as the first and only FDA-approved biologic designed to specifically bind to and inhibit the interleukin (IL)-13 cytokine. This expansion encompasses those whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
December 15, 2023: FDA Approves Historic Roflumilast Foam 0.3% For Seborrheic Dermatitis
Arcutis Biotherapeutics announced the FDA approval of roflumilast foam 0.3% (ZORYVE) for the treatment of seborrheic dermatitis in patients aged 9 years and older. Most notably, roflumilast foam 0.3% is a once-daily steroid-free foam and the first FDA-approved drug for seborrheic dermatitis with a new mechanism of action in over 2 decades. Roflumilast foam provides rapid disease clearance and significant reduction in itch. In the roflumilast foam-treated arm of the pivotal phase 3 STRATUM study (NCT04973228), at week 8, nearly 80% of patients achieved the primary efficacy endpoint of IGA Success and just over 50% of patients reached complete clearance.