22:10 uur 21-07-2022

Innovaderm schittert als belangrijke partner in klinische ontwikkeling en studiebeheer van nieuw door de FDA goedgekeurd geneesmiddel voor psoriasis, tapinarof

MONTREAL–(BUSINESS WIRE)– De betrokkenheid van Innovaderm bij alle fasen van de klinische ontwikkeling van tapinarof culmineerde in een geweldige prestatie: de recente goedkeuring van de VTAMA® (tapinarof) crème van Dermavant Sciences door de FDA voor de behandeling van plaque psoriasis bij volwassenen.

Tapinarof, ontdekt in Canada, is in de Verenigde Staten goedgekeurd voor de behandeling van psoriasis, een chronische huidaandoening die jeukende, schilferige plekken op verschillende delen van het lichaam veroorzaakt en een aanzienlijk nadelig effect heeft op de kwaliteit van leven.

“Dit is een geweldige mijlpaal voor patiënten – een mijlpaal waar we al jaren naartoe werken”, zegt dr. Robert Bissonnette, oprichter en CEO van Innovaderm. “Innovaderm is goed gepositioneerd om bedrijven zoals Dermavant te helpen innovatie vooruit te helpen door hen te begeleiden in alle stadia van hun klinisch onderzoek, van het schrijven van protocollen tot gegevensanalyse. We speelden niet alleen een instrumentele rol door onze deelname aan multicenter fase 2 en 3 studies, maar we waren ook de eersten die de werkzaamheid van tapinarof aantoonden in proof-of-concept studies bij zowel psoriasis als atopische dermatitis.”

Innovaderm Shines as Key Partner in Clinical Development and Study Management of Newly FDA-Approved Psoriasis Drug, Tapinarof

MONTREAL–(BUSINESS WIRE)– Innovaderm’s involvement in all phases of the clinical development of tapinarof culminated with a tremendous achievement: the recent approval of Dermavant Sciences’ VTAMA® (tapinarof) cream by the FDA for the treatment of plaque psoriasis in adults.

Discovered in Canada, tapinarof is approved in the United States for the management of psoriasis, a chronic skin condition that causes itchy, scaly patches on different parts of the body and has a significant detrimental effect on quality of life.

“This is a great milestone for patients – one that we have been working towards for years,” says Dr. Robert Bissonnette, Innovaderm’s founder and CEO. “Innovaderm is well-positioned to help companies such as Dermavant drive innovation forward by accompanying them in all stages of their clinical research from protocol writing to data analysis. We not only played an instrumental role through our participation in multicenter phase 2 and 3 studies, but we were also the first to demonstrate tapinarof’s efficacy in proof-of-concept studies in both psoriasis and atopic dermatitis.”

VTAMA® cream is a once-daily, topical medication for psoriasis. Currently, clinical trials are underway to study this medication among patients with atopic dermatitis.

“VTAMA® cream is a non-steroidal topical that is a new chemical entity and the first-in-class therapy to be approved in the topical psoriasis space in 25 years,” says Anna Tallman, PharmaD, Vice-President of Medical Affairs at Dermavant Sciences. “We appreciate the collaboration and partnership with Dr. Bissonnette and Innovaderm to help bring forward an effective new treatment option in the United States that has the potential to benefit adults with plaque psoriasis across the entire disease severity spectrum – from mild to severe.”

Dr. Bissonnette and Tallman recently contributed to an article on the phase 3 tapinarof studies, which was published in the New England Journal of Medicine. To learn more: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2103629

For information on Innovaderm’s early to late phase study capabilities, visit our website.


Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist approved in the US 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.

Innovaderm Research Inc.

Innovaderm Research Inc. is a global, full-service CRO specialized in therapeutic dermatology. Founded in 2000, it partners with biotechnology and pharmaceutical companies for the collaborative management of early to late phase clinical trials. Its mission is to drive innovative research initiatives and offer new therapies for patients living with skin disease.

Dermavant Sciences

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 both approved and late-stage development product candidates the company believes may address important immuno-dermatological conditions, including plaque psoriasis and atopic dermatitis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).


For more information:
Kathy Giangaspero

Communications Specialist

Innovaderm Research Inc.


Anna Tallman

Vice-President, Medical Affairs

Dermavant Sciences


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