PSORIASIS

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.

Key Points: 
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • Patients who were randomized to tapinarof in PSOARING 1 or 2 and who also completed PSOARING 3 received tapinarof treatment for up to 52 weeks.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

DGAP-News: Temedica announces cooperation with Bristol Myers Squibb for the development of a digital companion for psoriasis patients

Retrieved on: 
Tuesday, March 15, 2022
People, Psoriasis, Bristol Myers Squibb, Quality of life, Technology, Health, Patient, Obesity, Cardiovascular disease, Science, Diabetes, Inflammatory bowel disease, Metabolic syndrome, BioNTech, Physician, HIV disease progression rates, Prescription, United, Disease, Pharmaceutical industry, Medical device, Psoriasis, Temedica GmbH, PSORIASIS, TEMEDICA GMBH

Munich, Germany, March 15, 2022 - Temedica GmbH, a leading digital health and health insights company, today announced its cooperation with Bristol Myers Squibb to develop a digital companion for patients with psoriasis.

Key Points: 
  • Munich, Germany, March 15, 2022 - Temedica GmbH, a leading digital health and health insights company, today announced its cooperation with Bristol Myers Squibb to develop a digital companion for patients with psoriasis.
  • Psoriasis affects each patient differently, so we integrate the advice of patients as well as healthcare professionals in designing a digital companion that meets the patients' needs.
  • Dr. Michael May, Medical Director at Bristol Myers Squibb, Germany, said:
    "We are happy to support the development of an innovative digital patient companion.
  • The digital companion will enable psoriasis patients to gain a better understanding of their individual disease course and potential influencing factors.

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
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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
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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 ).

Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency

Retrieved on: 
Monday, November 29, 2021
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Deucravacitinib, the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies, Psoriasis, Bristol Myers Squibb, DEUCRAVACITINIB, THE PHASE 3 POETYK PSO-1 AND POETYK PSO-2 STUDIES, PSORIASIS, BRISTOL MYERS SQUIBB

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.
  • These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
  • Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.
  • Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities.

Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

Retrieved on: 
Thursday, September 30, 2021
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Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021.
  • These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 4:45 p.m. CEST.
  • Bristol Myers Squibb-sponsored abstracts presented at EADVs 30th Anniversary Congress can be found below and accessed online here .
  • Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on dermatologic immune-mediated diseases.

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
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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.