Dermavant’s Phase 3 Program for Tapinarof in Psoriasis

Dermavant to Present New Data from the Phase 3 PSOARING 3 Long-Term Extension Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 11, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cream, People, Atopic dermatitis, Safety, Hypertension, Psoriasis Area and Severity Index, Ageing, Twitter, Psoriasis, American Academy, AAD, Patient, QD, Risk, Boston Convention and Exhibition Center, Research, Therapy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PGA, Diabetes, BSA, Exhibition, Quality of life, Depression, DLQI, Acne, Roivant Sciences, Dermatology Life Quality Index, Efficiency, Obesity, PDUFA, Skin, Vitiligo, Week, PASI, Inflammatory bowel disease, Food, Adult, LinkedIn, New Drug Application, Pharmaceutical industry, Cosmetics, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Tapinarof is a novel, non-steroidal, once-daily therapeutic aryl hydrocarbon receptor modulating agent which is formulated in a cosmetically elegant cream.

Key Points: 
  • Tapinarof is a novel, non-steroidal, once-daily therapeutic aryl hydrocarbon receptor modulating agent which is formulated in a cosmetically elegant cream.
  • In August 2021, the U.S. Food and Drug Administration (FDA) accepted for filing the companys New Drug Application for tapinarof for the treatment of plaque psoriasis in adults.
  • PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Dermavant Presents New Patient Satisfaction Data from PSOARING 3 Long Term Extension Trial of Tapinarof in Adults with Plaque Psoriasis at the 2022 Winter Clinical Dermatology Conference

Retrieved on: 
Saturday, January 15, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, People, Atopic dermatitis, Ageing, New Drug Application, Roivant Sciences, Patient, Research, Vitiligo, Week, Conference, Acne, Psoriasis, LinkedIn, Dermatitis, Perception, Inflammatory bowel disease, Safety, Adult, PGA, Patient satisfaction, QD, Obesity, Hypertension, Skin, National Psoriasis Foundation, Oslo bid for the 2022 Winter Olympics, Diabetes, Efficiency, Quality of life, Depression, Therapy, Risk, Twitter, FDA, Physician, Pharmaceutical industry, Medical device, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

These results were presented during the 2022 Winter Clinical Dermatology Conference, held January 14-19 in Koloa, Hawaii.

Key Points: 
  • These results were presented during the 2022 Winter Clinical Dermatology Conference, held January 14-19 in Koloa, Hawaii.
  • Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
  • PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Dermavant to Present New Data from Phase 3 PSOARING Program at the 2022 Winter Clinical Dermatology Conference

Retrieved on: 
Friday, January 7, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, People, Grand Promenade, Safety, QD, Acne, Atopic dermatitis, Food, Poster, Vitiligo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Psoriasis, Skin, Therapy, Roivant Sciences, Depression, Research, Patient, Adult, Inflammatory bowel disease, PDUFA, Obesity, Quality of life, Conference, Twitter, Ageing, Week, Efficiency, PGA, Diabetes, Hypertension, LinkedIn, FDA, New Drug Application, Risk, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.
  • Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

Retrieved on: 
Thursday, September 30, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Linda, People, Food, Journal of the European Academy of Dermatology and Venereology, Week, Henry Ford, Efficiency, Dermatologic Clinics, Skin, Patient, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Plaque, Depression, FDA, QD, PGA, Henry Ford Health System, Adult, Hypertension, Vitiligo, Drug discovery, LinkedIn, Diabetes, Twitter, Remittance, Roivant Sciences, Psoriasis, Ageing, Acne, New Drug Application, Risk, Atopic dermatitis, Tachyphylaxis, Research, Maintenance, Obesity, Inflammatory bowel disease, Safety, Quality of life, Doctor of Philosophy, Global Assessment of Functioning, Yale School of Medicine, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

Key Points: 
  • The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
  • Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older.

Dermavant to Present New Data on Phase 3 PSOARING Program at 30th EADV Virtual Congress

Retrieved on: 
Thursday, September 23, 2021
Research, Medical Devices, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Cream, Linda, People, EDT, Food, Week, Time, Efficiency, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Journal of the European Academy of Dermatology and Venereology, Depression, FDA, QD, PGA, Adult, Vitiligo, Hypertension, LinkedIn, Diabetes, Twitter, New Drug Application, Roivant Sciences, Psoriasis, Ageing, Acne, Risk, Atopic dermatitis, PDUFA, Research, Obesity, Inflammatory bowel disease, Safety, Quality of life, CET, Skin, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its Phase 3 PSOARING long-term extension study at the 30th European Academy of Dermatology and Venerology (EADV) Virtual Congress, to be held September 29through October 2, 2021.

Key Points: 
  • Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its Phase 3 PSOARING long-term extension study at the 30th European Academy of Dermatology and Venerology (EADV) Virtual Congress, to be held September 29through October 2, 2021.
  • Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).

Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

Retrieved on: 
Tuesday, August 10, 2021
Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, People, Vitiligo, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, New Drug Application, Diabetes, Safety, LinkedIn, Patient, Skin, Quality of life, Efficiency, Food, Pain, Risk, Atopic dermatitis, QD, Ageing, Hypertension, Adult, File, Research, Twitter, Psoriasis, Multimedia, NDA, Roivant Sciences, Depression, Week, Inflammatory bowel disease, FDA, Acne, PDUFA, PGA, Obesity, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Estimates suggest that psoriasis, a chronic and debilitating condition, impacts 8 million people in the United States and 125 million people worldwide.

Key Points: 
  • Estimates suggest that psoriasis, a chronic and debilitating condition, impacts 8 million people in the United States and 125 million people worldwide.
  • Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 8090% of people with psoriasis.
  • PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

Retrieved on: 
Thursday, June 3, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical trials, Organ systems, Psoriasis, Medical specialties, Immunology, Immunosuppressants, Monoclonal antibodies, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.

Key Points: 
  • Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.
  • Todays NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps.
  • PSOARING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Dermavant to Showcase PASI90, Itch and Quality of Life Data from Phase 3 Pivotal Trials for Tapinarof at AAD VMX 2021

Retrieved on: 
Friday, April 23, 2021
Biotechnology, Other Health, Health, Pharmaceutical, Clinical trials, Organ systems, Psoriasis, Dermatology Life Quality Index, Medical specialties, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

A minimal clinically important difference of \xe2\x80\x934.0 in DLQI was exceeded at Week 12 for patients treated with tapinarof (\xe2\x80\x935.0 in PSOARING 1; \xe2\x80\x934.7 in PSOARING 2).

Key Points: 
  • A minimal clinically important difference of \xe2\x80\x934.0 in DLQI was exceeded at Week 12 for patients treated with tapinarof (\xe2\x80\x935.0 in PSOARING 1; \xe2\x80\x934.7 in PSOARING 2).
  • Subjects in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies.
  • The company reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210423005088/en/\n'

Dermavant Announces Tapinarof Data Presentations at the AAD VMX 2021

Retrieved on: 
Friday, April 16, 2021
Health, Other Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant

Subjects in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies.

Key Points: 
  • Subjects in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies.
  • PSOARING 3 consists of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
  • As such, subjects who received drug during PSOARING 1 and PSOARING 2, completed PSOARING 3 having received treatment with tapinarof cream for up to 52 weeks.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210416005079/en/\n'

Dermavant Announces Tapinarof Data Presentation at the Innovations in Dermatology Conference

Retrieved on: 
Thursday, March 11, 2021
Biotechnology, Other Health, Health, Pharmaceutical, Clinical trials, Life sciences, Biotechnology, Psoriasis, Roivant Sciences, Biopharmaceutical, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant

PSOARING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.

Key Points: 
  • PSOARING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • PSOARING 3 consists of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
  • Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).