Zoryve from Arcutis Approved for Plaque Psoriasis

The FDA has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% from Arcutis Biotherapeutics for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older.

The only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, Zoryve provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. Zoryve is a once-daily, steroid-free cream in a safe and well tolerated formulation designed to be patient-friendly.

“In multiple clinical trials, Zoryve was proven to be safe and effective, with improvements in disease clearance in hard-to-treat areas like knees and elbows, as well as in sensitive areas such as the face, genitalia, and intertriginous areas. Zoryve is very well tolerated, which is an important consideration for treating a chronic skin disease such as plaque psoriasis,” says Mark Lebwohl MD, FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “With this FDA approval, adults and adolescents with psoriasis and their dermatologists have a new steroid-free treatment option for use on all affected areas of the body.”

Zoryve features HydroARQ Technology, a proprietary drug delivery formulation that creates a non-greasy moisturizing cream that spreads easily and absorbs quickly.

Arcutis intends to make Zoryve widely available via key wholesaler and national dermatology pharmacy channels as a new treatment option by mid-August, and the company is dedicated to affordable access to therapy. The Zoryve Direct patient support program will help commercially insured individuals with plaque psoriasis get access and start Zoryve treatment as prescribed by their health care provider quickly and easily by helping them navigate the payer process, lowering the out-of-pocket cost for eligible patients, and offering programs that support staying on therapy.

Arcutis will also offer the Arcutis Cares patient assistance program (PAP)— the first of its kind for a topical psoriasis treatment—that will provide Zoryve at no cost for financially eligible patients who are uninsured or underinsured.

Incyte’s Opzelura Adds Vitiligo Indication

Opzelura (ruxolitinib) cream 1.5% from Incyte is now approved for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is the only FDA-approved treatment for repigmentation in patients with vitiligo and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the US.

In patients with non-segmental vitiligo, Opzelura is approved for continuous topical use twice daily to affected areas of up to 10% body surface area. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks.

FDA approval was based on data from the pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura versus vehicle in more than 600 people with nonsegmental vitiligo, age 12 and older. In the studies, treatment with Opzelura resulted in significant improvements in VASI scores, which represent improvements in facial and total body repigmentation at Week 24 (primary analysis) compared to vehicle (non-medicated cream) and in an open-label extension at Week 52.

Results at Week 24, which were consistent across both studies, showed that approximately 30% of patients treated with Opzelura achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to approximately 8% and 13% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively. At Week 52, approximately 50% of Opzelura-treated patients achieved F-VASI75.

Additionally, at Week 24, more than 15% of patients treated with Opzelura achieved ≥90% improvement from baseline in F-VASI (F-VASI90), compared to approximately 2% of patients treated with vehicle. At Week 52, the percentage of Opzelura-treated patients who achieved F-VASI90 doubled to approximately 30%.

In the vehicle controlled period of the Phase 3 studies, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia1. The labeling for Opzelura includes a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. See additional Important Safety Information below.

“Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat,” says David Rosmarin, MD, Vice Chair of Research and Education, Department of Dermatology at Tufts Medical Center. “There have been no FDA-approved therapies available to date and the approval of Opzelura therefore marks a significant milestone. I welcome a medical treatment that helps my patients with nonsegmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease.”

Eligible patients in the US who are prescribed Opzelura have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a program offering patient support, including financial assistance and ongoing education and resources to eligible patients. Information about IncyteCARES is available online or by calling 1-800-583-6964..

FDA Nod for Stelara in Pediatric PsA

The FDA approved Stelara (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA).

Stelara is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases. Stelara is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.

The FDA’s approval was based on pharmacokinetic (PK) data and extrapolation of the established efficacy and existing safety profile of Stelara in multiple Phase 3 studies in adult and pediatric patients with moderate to severe plaque PsO (PSTELLAR, CADMUS, and CADMUS Jr) and adult patients with active PsA (PSUMMIT I and II). With the limited availability of pediatric PsA patients for inclusion in clinical trials, researchers utilized an extrapolation approach based on previous PK, efficacy and safety observations from a closely adjacent population of pediatric patients with moderate to severe plaque PsO who also had active PsA, as well as adult patients with moderate to severe plaque PsO or active PsA. An analysis of the data demonstrated that PK exposure of Stelara in these pediatric PsO patients with active PsA was consistent with that of Phase 3 clinical trials of Stelara in pediatric PsO patients without active PsA, as well as with adult patients with moderate to severe plaque PsO or adult patients with active PsA, while data on common efficacy endpoints were similar in these pediatric PsO patients with active PsA.

Janssen says it is actively working toward greater patient accessibility through improved commercial first-line formulary coverage, as well as patient-specific support services specifically for patients to start and stay on Stelara treatment after a prescribing decision has been made.

Stelara withMe offers a comprehensive support program that helps patients get started on Stelara and stay on track. Stelara withMe provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Stelara withMe Savings Program for commercially insured patients who are eligible.

Novan’s Berdazimer Gel Performs Well in Phase 3 for Molluscum: Study

Novan, Inc.’s berdazimer gel, 10.3% significantly out-performed placebo for the treatment of molluscum, according to results of the B-SIMPLE 4 pivotal Phase 3 clinical study published in JAMA Dermatology. Berdazimer gel, 10.3% is a potential first-in-class topical nitric oxide-based prescription treatment.

In the Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4 multicenter, vehicle-controlled, double-blind study, 891 patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. Study participants were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions, compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema.

Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of those on active treatment achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of those receiving vehicle only. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a ≥90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients.

Novan says it plans to submit a New Drug Application for berdazimer gel, 10.3% to FDA before the end of this year.

There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that if approved, topical berdazimer gel, 10.3% as a prescription, self- or caregiver-applied therapy would satisfy an important patient care need for the treatment of molluscum.

What a Wonderful World

Camp Wonder allows kids with skin diseases to be … kids.

By Denise Mann

Each morning, the 75-plus kids at Camp Wonder wake up in their cabins as pop music tunes blare from the speakers.

From there, it’s a day filled with activities including zip lining, horseback riding, swimming, ceramics, tennis, and more. And each day is capped off with a special evening activity including a carnival, talent show, and even a prom.

Sure, Camp Wonder sounds a lot like most summer camps, but this one is special for many reasons.

Founded by the Children’s Skin Disease Foundation (CSDF) and supported by Galderma, Camp Wonder is a medically staffed summer camp program for children ages 7 to 16 with serious skin diseases. It is free for all campers and their families. This summer, Camp Wonder was held from July 2-8 at Camp Twin Lakes in Rutledge, GA.

CSDF was founded by Francesca Tenconi. At age 11, she was diagnosed with pemphigus foliaceous. For her sixteenth birthday, she asked family and friends to donate money to start a non-profit group that would address the challenges facing kids with skin diseases. CSDF, which sponsors Camp Wonder, was born a week later on June 3, 2000.

“As a kid, I really wanted to meet other kids like me, and there weren’t any around,” she recalls. “Kids just want to have fun, and support groups were too heavy.”

So far, more than 2,000 children with skin diseases, including vitiligo, pemphigoid, Epidermolysis Bullosa, ichthyosis, ectodermal dysplasia, and Garlin Syndrome, have attended Camp Wonder, which just wrapped its twenty-second summer.

Camp Wonder is a vacation for the kids and their parents, she says. “Campers find support joy and laughter and have one place where they are not stared at and parents get a break and know their kids are getting excellent care.”

These kids don’t always feel comfortable in public pools because of their visible skin conditions, but at Camp Wonder, they are just regular kids, making friends and having fun. The CSDF also sponsors Wonder Wish, an initiative that grants wishes to Camp Wonder families. Every camper that has participated in Camp Wonder since 2001 can make a wish.

Galderma Gives Back

This is Galderma’s 10th year supporting the camp. “Their mission is so closely aligned with ours, that it was a natural fit from the start,” says Lisa Morris, general manager of the US Consumer Business Unit at Galderma.

To date, Galderma has donated more than $1.7 million and approximately 50,000 Cetaphil products to the Camp Wonder infirmary, along with helping to staff the camp. “People apply, and it is a coveted position,” Morris says. Galderma also sponsors the annual Wonder Run, a 5K race that will take place in Dallas this October, where 100% of registration fees and donations go directly toward CSDF and Camp Wonder.

The camp is staffed with 40 volunteer dermatologists, residents, and nurses. Stefani Takahashi, MD, a clinical professor of dermatology, director, USC Dermatology Residency Program and director, Medical Student Dermatology Advisory Program and Vice Chair of Education at the Keck School of Medicine at the University of Southern California and Jenny Kim, MD, PhD, assistant professor, division of dermatology, David Geffen School of Medicine at the University of California, Los Angeles (UCLA), cofounded the camp with Tenconi.

“It’s a great experience for residents to see kids with skin diseases outside of the clinic,” Tenconi says. “They can see and really understand the impact of the skin disease, and they get to spend quality time with kids during arts and crafts or at the pool.” This offers a much broader perspective than seeing these kids in the clinic for brief appointments.

New York City-based dermatologist Camille Howard-Verovic, DO partnered with Galderma to attend Camp Wonder. “I get to see rare skin diseases that the public doesn’t see all the time and see how they affect children,” she says. “These diseases affect children and families tremendously, and Camp Wonder is a space where these children get to be kids … even for one week.”

Get Involved

Dermatologists can refer campers or volunteer via the CSDF referral page at csdf.org/get-involved.