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Dermavant Announces Approval of Tapinarof in both Psoriasis and Atopic Dermatitis in Japan

2024年06月25日 PM09:00
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LONG BEACH, Calif. & BASEL, Switzerland

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that Japan Tobacco has received approval in Japan for tapinarof cream, 1% for the treatment of both adults with psoriasis and patients 12 years of age and older with atopic dermatitis.

“I believe Japan Tobacco’s approval speaks to tapinarof’s unique proposition in Japan as a once-daily, cosmetically elegant and steroid-free, topical cream for both acute treatment and long-term management of psoriasis and atopic dermatitis and we applaud our partner’s success,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Our commitment to bringing VTAMA (tapinarof) cream, 1% to as many U.S. patients as we can remains resolute. We are currently focused on preparing for the commercial launch of VTAMA cream, subject to FDA approval, for its second U.S. indication of atopic dermatitis, and look forward to the PDUFA date for our Supplemental New Drug Application in Q4 2024.”

Under the terms of the 2020 license agreement, Dermavant received an upfront payment of $60 million, with up to a further $53 million payable upon the achievement of certain development milestones for tapinarof for the treatment of psoriasis and atopic dermatitis including $28 million for approval in Japan. In addition, Dermavant has the right to receive royalties based on product sales of tapinarof in Japan.

VTAMA cream, 1% is a novel, aryl hydrocarbon receptor agonist in development in the U.S. as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD). VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. In April 2024, the U.S. Food and Drug Administration (FDA) accepted the company’s sNDA for VTAMA® (tapinarof) cream, 1% for the topical treatment of AD in adults and children 2 years of age and older. The Prescription Drug User Fee Act (“PDUFA”) action date assigned by the Agency is in Q4 2024.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, extension trial.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration.

For more information, please visit http://www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

©2024 Dermavant Sciences, Inc. All Rights Reserved. All trademarks are the property of Dermavant Sciences, GmbH.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240625865698/en/

CONTACT

dna Communications:

Angela Salerno-Robin

Senior Vice President, Media Relations, Healthcare

ASalerno-Robin@dna-comms.com

212-445-8219

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