Monumental regulatory approvals are taking dermatologic care to new levels as we close out 2023. From long-awaited topicals to novel acne drugs, these new approvals by the U.S. Food and Drug Administration (FDA) represent significant milestones and promise renewed hope for patients who have been lacking options for years.
Below, we spotlight several of 2023’s most transformative approvals poised to reshape dermatological care. Whether curing disfiguring outbreaks, improving access through convenience, or elevating psychosocial health, their relevance cannot be overstated.
Brella (April 2023)
The FDA cleared Candesant Biomedical’s Brella™ early in the year, which is a three-minute SweatControl Patch used for the treatment of primary axillary hyperhidrosis in adults. The patch, which uses Candesant’s patented TAT (targeted alkali thermolysis) technology, is applied to the patient’s underarm for approximately three minutes, is noninvasive, needle-free, and provides relief for up to three or four months.
The pivotal SAHARA study reached both its primary and secondary endpoints, showing a reduction in sweating and an improved quality of life. Doris J. Day, MD, clinical associate professor of dermatology at the New York University Langone Medical Center, stated, “Brella provides an easy conversation starter for us health care providers and our patients because it provides a simple, in-office approach to sweat control that is fast, comfortable, non-invasive, needle-free, aluminum-free, and affordable, and with results lasting 3 to 4 months.”
VYJUVEK (May 2023)
Krystal Biotech received FDA approval for VYJUVEK™ (beremagene geperpavec-svdt) in May. This is the first-ever redosable gene therapy treatment for dystrophic epidermolysis bullosa (DEB), the serious and rare genetic disease that affects the skin and mucosal tissues. VYJUVEK, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, is a non-invasive, topical, and redosable therapy approved for patients aged six months and older with recessive or dominant DEB. Clinical trial results of GEM-1/2 and GEM-3 demonstrated that at six months, complete wound healing was seen in 67% of those treated with VYJUVEK compared to 22% of those exposed to placebo. Furthermore, complete wound healing at three months was seen in 71% of VYJUVEK-treated patients compared to only 20% of those treated with placebo.
Due to its monumental significance in treating this devastating disease, VYJUVEK also received the Orphan Drug, Fast Track, Regenerative Medicine Advanced Therapy, and Priority Review designations and forms part of the FDA’s Rare Pediatric Disease Priority Review Voucher program.
LITFULO (June 2023)
In June, the FDA approved LITFULO™ (ritlecitinib) for the treatment of severe alopecia areata in patients aged 12 years and above. LITFULO, an inhibitor of JAK3 and the TEC family kinases, is a once-daily oral treatment and became the first and only FDA-approved treatment for adolescents with the condition. During the ALLEGRO Phase 2b/3a, a 48-week randomized trial of 718 patients, 23% of patients treated with ritlecitinib at the recommended dose of 50 mg had 80% or more scalp hair coverage after six months compared to only 1.6% of the placebo group.
Renowned dermatologist, Brett A. King, MD, PhD, principal investigator in the trial, spoke of the significance of this breakthrough treatment, stating, “Normalcy is so important for everybody, but especially when we are developing. So it is easy to understand what a monumental breakthrough it is to have a medicine, ritlecitinib, approved for adolescents. Ritlecitinib restores normalcy and will make life better — literally will change life — for so many people.”
More recently, LITFULO was also granted marketing authorization by the European Commission (EC) and was also approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to treat severe alopecia areata in people aged 12 and above.
YCANTH (July 2023)
July 2023 saw the approval of YCANTH™ (cantharidin) for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. YCANTH is a drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) and is delivered via a single-use applicator. It is precise and delivered by a provider in a clinical setting.
Both clinical trials for YCANTH (CAMP-1 and CAMP-2) met the primary endpoint of complete clearance of all treatable molluscum lesions and post-hoc analysis also revealed that the percentage of complete clearance at the end of the trial was significantly higher across all age groups.
BIMZELX (October 2023)
In October, BIMZELX® (bimekizumab-bkzx) became the first and only IL-17A and IL-17F inhibitor approved for the treatment of adults with moderate-to-severe plaque psoriasis. All three phase 3 trials (BE VIVID, BE READY, BE SURE) demonstrated consistent fast, complete, and lasting levels of skin clearance for up to one year, and it was generally well tolerated.
In speaking of this exciting advancement, Christopher G. Bunick, MD, PhD, associate professor of dermatology and physician-scientist at the Yale School of Medicine, stated, “The unique mechanism of action of BIMZELX allows dual neutralization of IL-17A and IL-17F, and dermatologists and psoriasis patients are now going to see first hand the rapid, powerful, and durable skin clearance BIMZELX has to offer from that extra IL-17F inhibition.” He adds that it is hopefully “only a short time before it is also approved for psoriatic arthritis, a devastating manifestation of psoriasis that is under-treated.”
Bimekizumab is now available as an autoinjector and a pre-filled syringe, which means it can be administered by a healthcare professional, or the patient can opt to do it themself after receiving proper training.
CABTREO (October 2023)
Bausch Health and its dermatology business, Ortho Dermatologics, announced the approval of its long-awaited fixed-dose, triple-combination topical treatment for acne vulgaris, CABTREO™ (clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%) in October. Offering three mechanisms of action, an antibiotic, retinoid, and antibacterial, it provides a safe and effective treatment for acne. The combined efficacy results for both of the trials for CABTREO demonstrated approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12. CABTREO, which is approved for adults and children 12 years of age and older, is a very welcome addition to the acne armamentarium, opening new possibilities for the millions of acne sufferers in the U.S.
According to Dr. Bunick, “This is a game changer in efficacy for the topical therapy of acne for our acne patients. Here we have 3 medicines in a unique polymetric mesh that allows them to synergize unlike ever before, this is going to revolutionize compliance and therefore treatment success of our acne patients. I am thrilled that CABTREO is finally here, and I am excited to start using it in my patients and see how its real-world efficacy is.”
Cosentyx (October 2023)
At the end of October, Novartis announced the approval of Cosentyx® (secukinumab) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults. It became the second biologic approved for HS and the first interleukin-17A inhibitor. In both the SUNRISE and SUNSHINE trials, secukinumab was generally well tolerated and responses were maintained through 52 weeks. Both trials reported a larger proportion of patients treated with Cosentyx achieved at least a 50% decrease in abscess and inflammatory nodule count compared to placebo.
Speaking of the approval, Donna Atherton, EdD, founder and Chief Mission Officer of the International Association of Hidradenitis Suppurativa Network (IAHSN), stated, “HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities. It can have a major impact on me physically and emotionally, including feelings of anxiety, stress, and isolation. The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease.”
SKINVIVE (May 2023)
Allergan Aesthetics announced in May that the FDA approved SKINVIVE™ by JUVÉDERM®, the first and only hyaluronic acid intradermal microdroplet injection used to improve skin smoothness of the cheeks in adults aged 21 years and above. Studies leading up to the approval showed that 58% and 56% of patients treated with SKINVIVE saw a greater than or equal to 1-point improvement on the Allergan Cheek Smoothness Scale (ACSS) at one month and six months respectively.
Restylane Eyelight (June 2023)
Galderma’s Restylane® Eyelight was approved for the treatment of undereye hollows in adults aged 21 years and over in June. This undereye hyaluronic acid dermal filler is the first and only product in the U.S. that is formulated with non-animal stabilized hyaluronic acid (NASHA) technology for volume loss under the eyes.
Trials revealed that 87% of patients had reduced undereye hollowness at three months with 84% of patients still being pleased with their results at the one-year mark. A total of 93% of patients even expressed an interest in receiving the treatment again after 12 months.
As we bid 2023 farewell, these transcendent approvals offer a preview into dermatology’s promising outlook. Patients now have renewed options to curb suffering, specialists gain allies against previously stubborn illnesses, and researchers have springboards to drive further progress. As the landscape continues to expand, we celebrate this year’s advances while continuing to push boundaries.
- Candesant Biomedical Receives FDA Clearance of Brella™1, the First and Only 3-Minute SweatControl Patch™, to Significantly Reduce Primary Axillary Hyperhidrosis. Candesant Biomedical
- Doris Day, MD, Discusses Primary Axillary Hyperhidrosis and Brella SweatControl Patch. Dermatology Times
- Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa. Krystal Biotech
- FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata. Pfizer
- European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata
- MHRA authorises Pfizer’s Litfulo for alopecia areata. Pharmaceutical Technology
- Verrica Pharmaceuticals Announces FDA Approval of YCANTH™ (cantharidin) topical solution 0.7%. Verrica Pharmaceuticals
- BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis. UCB
- FDA Approves CabtreoTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel For The Treatment Of Acne Vulgaris In Patients Twelve Years Of Age And Older. Bausch Health.
- Adding Cabtreo to the Acne Vulgaris Tool Box. Dermatology Times
- FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade. Novartis
- SKINVIVE™ by JUVÉDERM® Receives U.S. FDA Approval. Abbvie
- Galderma Receives FDA Approval for its Newest Hyaluronic Acid Filler, Restylane® Eyelight. Galderma