2025 FDA added indications to dermatologic medications

The FDA added indications to five previously approved dermatology drugs in 2025. The added indications include two new indications for Dupixent (dupilumab), bringing the total number of diseases for which it is an FDA-approved medication to eight. The roster of drugs that gaineFDA go-aheads for expanded labels also included Opzelura (ruxolitinib) and Zoryve (roflumilast).

Zoryve cream for young children, foam for plaque psoriasis

In October 2025, the FDA expanded the label of Zoryve (roflumilast) cream 0.05% as a topical treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years. Earlier in the year, in May 2025, the drug regulator gave its blessing to Zoryve foam 0.3% as a topical treatment for plaque psoriasis of the scalp and body in adults and adolescents aged 12 and older.

Zoryve cream is approved in a variety of concentrations as a treatment for plaque psoriasis and atopic dermatitis, but the 2025 approval was notable because it extended the cream’s approval into the very young pediatric population.

As a foam, Zoryve is approved for seborrheic dermatitis in adult and pediatric patients nine years of age as well as the recent approval for plaque psoriasis. The once-daily foam formulation is the first topical foam approved for psoriasis that may be especially beneficial for treatment in hair-bearing and sensitive areas.

Zoryve is a topical PDE4 inhibitor, designed to block a key inflammatory enzyme involved in psoriasis pathogenesis. Although PDE4 inhibition is not new — it is the mechanism of action of treatments such as Eucrisa (crisaborole) and Otezla — Zoryve — is a more potent PDE4 inhibitor.

"It is spectacular that roflumilast 0.3% foam is now approved for scalp and body psoriasis in adolescents and adults," said Dermatology Times Editor in Chief Christopher Bunick, M.D., Ph.D., in an interview. "This amazing foam vehicle not only delivers the highly potent PDE4 inhibitor roflumilast to the sites where patients need it most, but it does so in an elegant fashion. I am so excited psoriasis patients, like those with seborrheic dermatitis, have another safe, nonsteroidal therapeutic option."

https://www.managedhealthcareexecutive.com/view/fda-approves-zoryve-cream-0-05-for-young-children-with-atopic-dermatitis

https://www.dermatologytimes.com/view/fda-approves-arcutis-roflumilast-foam-for-plaque-psoriasis

Opzelura for atopic dermatitis in young children

In October 2025, the FDA approved Opzelura (ruxolitinib) as a treatment for mild to moderate atopic dermatitis in children ages 2 to 11 years. The label expansion made Opzelura the first topical Janus kinase (JAK) inhibitor approved for the pediatric population in the U.S. .

“This gives us another tool in a much-needed area,” Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine and founding director of the Chicago Integrative Eczema Center, told Dermatology Times. “A rapid, steroid-sparing option that meaningfully reduces itch within days helps us control flares without escalating to systemic therapy and can help minimize the use of topical steroids.”

The approval was based on the phase 3 TRuE-AD3 study, which enrolled 330 children ages 2 to 11 years with mild to moderate atopic dermatitis. The results showed that significantly more children treated with ruxolitinib achieved the primary end point of investigator’s global assessment treatment success (IGA-TS) compared with an inactive vehicle. Response rates were 36.6% with 0.75% cream and 56.5% with 1.5% cream compared with 10.8% for vehicle.

Opzelura was originally approved in 2011 as a treatment for atopic dermatitis in adolescents and adults. In 2022, the FDA approved it as a treatment for nonsegmental vitiligo.

https://www.dermatologytimes.com/view/fda-approval-brings-new-non-steroidal-option-for-pediatric-ad

Libtayo for adjuvant squamous cell carcinoma therapy

In October 2025, the FDA approved Libtayo (cemiplimab) as a treatment for cutaneous squamous cell carcinoma that has a high risk of recurring after it has been treated with surgery and radiation.

As a PD-1 inhibitor, Libtayo targets receptors on T cells and, in doing so, unleashes the T cells so they recognize and attack cancer cells. Originally approved in 2018, Libtayo had previously been approved as a treatment for metastatic and locally advanced basal cell carcinoma and certain types of non-small cell lung cancer. The original approval was as a treatment for metastatic cutaneous squamous cell carcinoma or locally advanced in individuals who weren’t candidates for curative surgery or curative radiation.

“Patients whose CSCC [cutaneous squamous cell carcinoma] is at a high risk of recurrence following surgery and radiation often have the poorest outcomes. Until now, we lacked options to help prevent a devastating recurrence, and immunotherapy was only available for patients with advanced CSCC who were no longer candidates for curative surgery or curative radiation,” Vishal A. Patel, M.D., associate professor of dermatology and hematology/oncology at George Washington University, and director of the GW Cancer Center’s Cutaneous Oncology Program, said in a news release from Regeneron.

https://www.managedhealthcareexecutive.com/view/regeneron-s-libtayo-fda-approved-as-first-immunotherapy-to-reduce-recurrence-risk-in-high-risk-skin-cancer-patients

Vyjuvek for dystrophic epidermolysis bullosa patients at birth

In September 2025, the FDA expanded the label for Vyjuvek (beremagene geperpavec) to include dystrophic epidermolysis bullosa patients from birth. The changes to the label also changed the wound dressing requirements to make at-home use of Vyjuvek feasible.

Krish S. Krishnan, chairman and CEO of Krystal Biotech, the drug’s maker, said in a news release that by “providing patients and their caregivers the ability to apply Vyjuvek themselves, we have made it easier for patients to integrate Vyjuvek into their daily routines and lifestyle.”

Vyjuvek is a herpes-simplex virus type 1 vector-based gene therapy indicated for the treatment of dystrophic epidermolysis bullosa with mutations in the (COL7A1) gene. It is designed to deliver two copies of the COL7A1 gene when applied directly to dystrophic epidermolysis bullosa wounds. The drug was originally approved in 2023.

Dystrophic epidermolysis bullosa is a rare subtype of epidermolysis bullosa characterized by extreme skin fragility affecting the deeper dermal layer beneath the epidermis.

Dupixent for bullous pemphigoid, chronic spontaneous urticaria

https://www.managedhealthcareexecutive.com/view/regeneron-s-libtayo-fda-approved-as-first-immunotherapy-to-reduce-recurrence-risk-in-high-risk-skin-cancer-patients

In June 2025, the FDA approved Dupixent as a treatment for adult patients with bullous pemphigoid (BP), a rare inflammatory skin disease. Earlier in April, the FDA approved the resubmitted application of Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU).

Dupixent, a mainstay of treatment of inflammatory skin conditions, inhibits the signaling of interleukin-4 and interleukin-12, key drivers of the type 2 inflammation that underlies many chronic allergic and inflammatory conditions.

The FDA had previously approved Dupixent as a treatment for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.

Bullous pemphigoid is an autoimmune skin disorder that mainly affects older adults. The symptoms include severe itching, blisters, lesions and skin breakdown. A study published in the Journal of the American Academy of Dermatology estimated the prevalence in the U.S. to be 12 per 100,000 adults, which increases to nearly 38 per 100,000 among those aged 60 and older.

Chronic spontaneous urticaria is a chronic inflammatory skin disease driven in part by type 2 inflammation. It is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. But more than 300,000 people in the United States have chronic spontaneous urticaria that is inadequately controlled by antihistamines.

https://www.managedhealthcareexecutive.com/view/fda-approves-dupixent-as-first-targeted-treatment-for-bullous-pemphigoid-in-adults

https://www.managedhealthcareexecutive.com/view/fda-approves-dupixent-for-inflammatory-skin-disease