Approvals Expand Treatment Options

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The US Food and Drug Administration (FDA) recently approved 3 different treatment options, giving patients with plaque psoriasis, psoriatic arthritis, pediatric atopic dermatitis, and alopecia more options for treatment.

Boom in Biosimilars

Ustekinumab-ttwe (Pyzchiva) was approved for all indications in its reference medicine, including treatments for adult and pediatric patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. The biosimilar was developed by Samsung Bioepis Co., Ltd., and will be commercialized by Sandoz in the US.¹

The drug will be available in multiple forms: 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection, and a 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Additionally, the FDA has granted a provisional determination for interchangeability for ustekinumab-ttwe. This means that ustekinumab-ttwe can be expected to be substituted for its reference product, Stelara.

“This approval reflects our dedication to ensuring high-quality treatments are universally accessible,” Claire D’Abreu-Hayling, chief scientific officer of Sandoz, said in a news release. “By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards achieving our goal of delivering life-changing medicines to the patients who need them.”

Sandoz plans to launch ustekinumab-ttwe in the US in February 2025, positioning Pyzchiva to be among the first wave of ustekinumab biosimilars available in the US market. The US FDA has also approved 2 other biosimilars to ustekinumab, including ustekinumab-aekn (Selarsdi) and ustekinumab-auub (Wezlana).

Developed by Alvotech and commercialized by Teva, ustekinumab-aekn was approved in April 2024 and can be used in adults and children aged 6 and older. Ustekinumab-auub was approved in October 2023. Earlier this year, the FDA also accepted Accord BioPharma’s Biologics License Application for DMB-3115, a proposed ustekinumab biosimilar. The proposed biosimilar is anticipated to launch no later than May 15, 2025, pending FDA approval.

Progress in Pediatric Atopic Dermatitis

The FDA approved Arcutis Biotherapeutics’ supplemental new drug application (sNDA) for roflumilast (Zoryve) cream 0.15% for the treatment of patients aged 6 years and older with mild to moderate atopic dermatitis. Roflumilast cream is a once-daily, steroid-free topical designed to significantly reduce itch and manage atopic dermatitis long-term.²

“What is really unique about the profile of Zoryve cream is that it works quickly, but it’s also appropriate for long-term treatment. Oftentimes, we would have to go to 2 different therapies in order to address these different parts of the treatment. For [a patient with] atopic dermatitis, it’s important that you work quickly because this is a disease that has a lot of itching and symptoms that need to be relieved,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in an interview with Dermatology Times.

The FDA’s approval of Arcutis’ sNDA is based on positive results from the three phase 3 INTEGUMENT clinical trials, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic studies. INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600) were 2 identical, parallel-group, double- blind, vehicle-controlled, phase 3 clinical trials evaluating the safety and efficacy of roflumilast cream 0.15% or vehicle applied once-daily to affected skin for 4 weeks in 1337 adult and pediatric patients aged 6 years and older with mild to moderate atopic dermatitis.²

In INTEGUMENT-1 and INTEGUMENT-2, each study met its primary end point of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) and a 2-grade improvement from baseline at week 4 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001). In both studies, 40% of adult and pediatric patients treated with roflumilast cream achieved a vIGA-AD score of 0 or 1 at week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001), with significant improvement seen as early as week 1 (P<0.0001).

Over 40% of adult and pediatric patients treated with roflumilast cream achieved a 75% improvement in Eczema Area and Severity Index (EASI 75) at week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Patients treated with roflumilast also achieved significant improvements in EASI 75 compared to vehicle as early as week one in both INTEGUMENT studies.

The launch of roflumilast cream 0.15% is supported by the Zoryve Direct Program, a patient support initiative that assists with navigating the payer process and offers a savings card to help reduce out-of-pocket costs for eligible patients with commercial insurance. Additionally, the Arcutis Cares patient assistance program provides medication at no cost for financially eligible patients who are uninsured or underinsured.³

Solutions for Severe Alopecia Areata

Deuruxolitinib (Leqselvi; Sun Pharma), an oral Janus Kinase (JAK) inhibitor, was approved for the treatment of severe alopecia areata in adults. Deuruxolitinib operates by selectively inhibiting JAK1 and JAK2, proteins involved in the immune signaling pathways believed to contribute to hair loss in alopecia areata. The drug’s approval is based on the results of 2 phase 3 clinical trials, THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650), which together included 1220 patients with at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT).⁴

In these trials, patients started with an average of only 13% scalp hair coverage. By week 24, one-third of the patients treated with deuruxolitinib achieved at least 80% scalp hair coverage, with some achieving up to 90% coverage. The studies demonstrated a consistent upward trend in hair regrowth among patients, with no observed plateau in efficacy at the 24-week mark. The most common adverse events reported in clinical trials included headache, acne, and nasopharyngitis. Deuruxolitinib is contraindicated in patients who are CYP2C9 poor metabolizers or those taking moderate or strong CYP2C9 inhibitors.⁴

“I think the dream for all dermatologists focusing on hair is to have hair loss medications that can be provided to all, prescribed by all, and to have options. This is now the third optionthat’s come up in 2 years. It just enriches the landscape and gives more opportunities to patients,” Natasha Mesinkovska, MD, PhD, associate professor and vice chair for clinical research of dermatology at the University of California, Irvine, and investigator in the deuruxolitinib clinical development program, said in an interview with Dermatology Times.

References

1. Andrus A. FDA approves biosimilar ustekinumab-ttwe for all indications of reference medicine. Dermatology Times. July 1, 2024. Accessed July 31, 2024. https://www.dermatologytimes.com/view/fda-approves-biosimilar-ustekinumab-ttwe-for-all-indications-of-reference-medicine

2. Bader K. FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and older. Dermatology Times. July 9, 2024. Accessed July 31, 2024. https://www.dermatologytimes.com/view/fda-approves-roflumilast-cream-0-15-for-atopic-dermatitis-in-patients-aged-6-years-and-older

3. Buchanan L. Roflumilast cream 0.15% for atopic dermatitis now commercially available. Dermatology Times. July 29, 2024. Accessed July 31, 2024. https://www.dermatologytimes.com/view/roflumilast-cream-0-15-for-atopic-dermatitis-now-commercially-available

4. Buchanan L. The FDA approves deuruxolitinib for severe alopecia in adults. Dermatology Times. July 26, 2024. Accessed July 31, 2024. https://www.dermatologytimes.com/view/the-fda-approves-deuruxolitinib-for-severe-alopecia-in-adults