Steroid-Free Next Generation Topical Cream PrZORYVE™ Approved by Health Canada to Treat Plaque Psoriasis Anywhere on the Body
TORONTO, ON, May 1, 2023 — Arcutis Canada Inc., is pleased to announce that Health Canada has approved ZORYVE™ (roflumilast cream 0.3%), the first topical phosphodiesterase-4 (PDE4) inhibitor for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older. This milestone marks the first and only Health Canada approved non-steroidal topical cream in its class and the first topical option to be indicated for the treatment of plaque psoriasis involving intertriginous areas (areas of skin-to-skin contact).
As a once-daily steroid-free treatment, ZORYVE rapidly relieves and controls mild, moderate, and severe plaque psoriasis, across all body areas, not only the knees, and truncal area, but also more sensitive and challenging sites to treat such as the face and intertriginous areas1,3.
“The approval of ZORYVE gives prescribers and patients an important new option to address plaque psoriasis. It offers a new and unique formulation that was created with the patient in mind,” said Dr. Kim A. Papp, President and Founder, Probity Medical Research. “ZORYVE is the first of its kind, steroid-free, topical PDE4 inhibitor cream that can be used on all affected parts of the body, including difficult to treat and sensitive areas, which until now, was not possible for psoriasis patients.”
“We truly appreciate the support and partnership of the Canadian dermatology community, which played a central role in the development of ZORYVE, spearheading its initial development, and providing approximately one-third of all clinical trials participants,” said Frank Watanabe, President and CEO of Arcutis. “With this approval, we look forward to working with Canadian dermatologists to make ZORYVE available for their patients.”
The approval of ZORYVE is supported by data from two pivotal phase 3 studies with approximately 880 patients with mild, moderate, or severe chronic plaque psoriasis: DERMIS-1 and DERMIS-2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque psoriasIS One and Two) which evaluated ZORYVE 0.3% cream once daily compared to vehicle, as well as results from long-term safety studies1,3. Both pivotal studies achieved their primary endpoints and secondary endpoints, resulting in rapid and statistically significant improvements in clearance of psoriasis plaques and symptom reduction, including itch, in all affected areas of the body in patients treated with ZORYVE, with a favourable tolerability and safety profile and minimal adverse application site reactions1,3.
Approximately one million Canadians live with psoriasis, a chronic inflammatory skin condition4. Plaque psoriasis, the most common form, affects approximately 90% of people who have the condition, and appears as raised, scaly, red or purplish patches or plaques that can form anywhere on the body and can also be itchy and painful4.
“Living with plaque psoriasis comes with both physical and emotional challenges. Having a new topical option that is steroid-free and can be used even in the most awkward and private parts of the body offers the possibility for individuals with plaque psoriasis to have some freedom from the unpleasant symptoms that can weigh them down,” said Helen Crawford, Program Manager with the Canadian Association of Psoriasis Patients (CAPP).
ZORYVE features HydroARQ Technology™, a proprietary drug delivery formulation that helps enable a non-greasy cream that spreads easily and absorbs quickly1,5.
“We are very excited to announce the Health Canada approval of ZORYVE in plaque psoriasis. It’s a significant milestone and the first step in delivering on our promise to bring innovation to Canadians with immune-mediated skin diseases. We look forward to making the product available by the end of June,” said Jamie Lewis, Head of Arcutis Canadian operations. “The growing Arcutis footprint will allow us to continue to build our presence to meet the needs of healthcare providers and patients across the country.”
About Roflumilast Cream
Roflumilast cream is a topical cream formulation of a PDE4 inhibitor, roflumilast. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inﬂammatory mediators and decreases production of anti-inﬂammatory mediators. Arcutis is developing topical cream and foam formulations of roflumilast.
Roﬂumilast cream 0.3% (ZORYVE) is approved in Canada and in the United States for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream is being evaluated at lower doses for atopic dermatitis: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Roflumilast foam 0.3% is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.
For important safety information, please consult the ZORYVE Canadian product monograph here.
Arcutis Canada Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit www.arcutis.ca or follow Arcutis on LinkedIn, Facebook, and Twitter.
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis, the potential of real-world use results of roflumilast cream, the Canada commercial launch of ZORYVE in plaque psoriasis, and access and continued expansion in commercial coverage with payors. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Amanda Sheldon, Head of Corporate Communications
Eric McIntyre, Head of Investor Relations
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