FDA Approves Zoryve (roflumilast) Cream for the Treatment of Plaque Psoriasis

 

 

 

Arcutis Biotherapeutics, Inc.   an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA)   approval of the  the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and 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 — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis.

“Today Arcutis has reached a major milestone, with our ability to offer this next generation topical PDE4 inhibitor to both adults and adolescents with plaque psoriasis. Zoryve’s combination of efficacy, safety, and tolerability, coupled with our proprietary HydroARQ Technology formulation, is designed to fit into patients’ everyday lives with no restrictions on duration of use,” said Frank Watanabe, President and CEO of Arcutis. “Additionally, Zoryve has been shown to rapidly clear plaques and reduce itch across all areas of the body. Zoryve is the only topical for which data focused on the treatment of intertriginous plaques — a common area affected by plaque psoriasis — have been specifically generated. This FDA approval is the fruition of our efforts, and we are excited to launch Zoryve, with expected product availability by mid-August.”

Topical therapies remain the primary treatment option for the vast majority of individuals with plaque psoriasis, a common immune-mediated skin disease that affects approximately nine million people in the U.S. and is the most frequent type of psoriasis occurring in both adults and adolescents. Severity can range between mild, moderate, and severe, with itch being the most burdensome and frequently reported symptom.

While the disease may affect any area of the body, plaques in certain areas, like the face, elbows and knees, genitalia, and intertriginous areas (areas of skin-to-skin contact), present unique treatment challenges. As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.

“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,” said Mark Lebwohl M.D., 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.

“Plaque psoriasis is a challenging disease and finding the right treatment option can be complicated, especially if individuals have to use multiple treatments for different parts of their body. We welcome a new treatment option that can make a meaningful difference for adults and adolescents with plaque psoriasis,” says Leah M. Howard, President and CEO of the National Psoriasis Foundation. “Our hope is that new treatments translate into improved outcomes and help alleviate the burdens of chronic disease for people impacted by psoriasis.”

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 healthcare 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.^‡

With this approval, Arcutis has access to, and plans to draw, an additional $125 million tranche as part of the Company’s non-dilutive financing agreement with SLR Capital Partners. Combined with the Company’s cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2022, this additional $125 million will provide for capital resources of over $400 million to support the launch and commercialization efforts for Zoryve, as well as continue to advance the Company’s pipeline development initiatives.

 

 Ref : https://en.wikipedia.org/wiki/Roflumilast

Arcutis Submits Topical Roflumilast Cream New Drug Application for the Treatment of Adults and Adolescents with Plaque Psoriasis

Arcutis Biotherapeutics, Inc. In continuation of my update on  roflumilast has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.

 

 

Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments.

“Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise,” said Frank Watanabe, President and CEO of Arcutis. “Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, patients, and partners, for helping us reach this important milestone.”

Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population. The majority of patients develop “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and areas where two skin areas may touch or rub together.

Topical treatments are the mainstay of therapy for the vast majority of psoriasis patients, particularly those with mild-to-moderate disease, as well as many moderate-to-severe patients who use topicals in combination with other treatments. However, existing topical treatments often force physicians and patients to make difficult trade-offs between tolerability and long-term use, requiring the use of multiple products or complicated treatment schedules. Roflumilast cream has been designed to address the challenges posed to dermatologists and patients by existing topical therapies and aims to simplify the overall management of plaque psoriasis.

Arcutis’ submission is supported by positive data from Arcutis’ pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Roflumilast met its primary endpoint and had an ‘IGA Success’ rate of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.

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https://en.wikipedia.org/wiki/Roflumilast