INCYTE DERMATOLOGY

Incyte Announces 52-Week Data From the Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo

Retrieved on: 
Saturday, March 26, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, VITILIGO, TRUE-V, RUXOLITINIB CREAM (OPZELURA™), INCYTE DERMATOLOGY, INCYTE

Results at Week 52 in crossover patients (those who received 28 weeks of treatment with ruxolitinib cream after initial treatment with vehicle cream) were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1.

Key Points: 
  • Results at Week 52 in crossover patients (those who received 28 weeks of treatment with ruxolitinib cream after initial treatment with vehicle cream) were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1.
  • The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data there were no clinically significant application site reactions or serious treatment-related adverse events related to ruxolitinib cream.
  • These results are extremely encouraging and highlight the clinical potential of ruxolitinib cream for patients with vitiligo.
  • Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period.

Incyte Announces Multiple Abstracts from its Dermatology Portfolio have been Accepted for Presentation at the 2022 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Friday, March 18, 2022
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Cream, Treatment, Abstract, Adult, Health care, Research, 2021 Essex County Council election, Knowledge, Ciclosporin, Solution, Disease, Security (finance), Inflammation, Marketing, American Academy of Dermatology, Shanda, Hidradenitis suppurativa, New Drug Application, Adolescence, U.S. Securities and Exchange Commission, Atopic dermatitis, JAK, Safety, Therapy, MAA, VALIANT, Clinical trial, AAD, Annual report, Azathioprine, Program, American Academy, Natural history, FDA, Company, Randomness, AD, Mental health, United, Week, Autoimmunity, COVID-19, Pharmaceutical industry, Cosmetics, Dermatology, Patient, Vitiligo, Incyte, Ruxolitinib Cream (Opzelura™), Incyte Dermatology, Incyte, RUXOLITINIB CREAM (OPZELURA™), INCYTE DERMATOLOGY, INCYTE

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology (AAD) Annual Meeting, held March 25-29, 2022, in Boston.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology (AAD) Annual Meeting, held March 25-29, 2022, in Boston.
  • Efficacy and Safety of Ruxolitinib Cream Monotherapy for the Treatment of Vitiligo: Results from Two 52-Week Phase 3 Studies (Session: S026 Late-Breaking Research: Clinical Trials.
  • ET; ePoster only)
    Full abstracts will be available on the AAD website on March 25, 2022.
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Incyte Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream (Opzelura™) as a Treatment for Patients with Vitiligo

Retrieved on: 
Tuesday, December 14, 2021
Medical Supplies, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Vitiligo, TRuE-V, Ruxolitinib Cream (Opzelura™), Incyte Dermatology, Incyte, VITILIGO, TRUE-V, RUXOLITINIB CREAM (OPZELURA™), INCYTE DERMATOLOGY, INCYTE

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists.

Key Points: 
  • The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists.
  • The FDAs acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.
  • Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period.
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Incyte Announces the Validation of the European Marketing Authorization Application for Ruxolitinib Cream in Vitiligo

Retrieved on: 
Thursday, October 28, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Safety, MAA, European Academy of Allergy and Clinical Immunology, Research, Vitiligo, Disease, BID, Knowledge, Annual report, Depigmentation, European Medicines Agency, Melanocyte, EMA, Security (finance), U.S. Securities and Exchange Commission, Patient, FDA, INT, Food, Face, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Life, Atopic dermatitis, Marketing, Company, Congress, Body surface area, VNS, COVID-19, Inflammation, Skin, AD, JAK, Program, Hidradenitis suppurativa, Solution, Classification, Therapy, BSA, Population, Prevalence, Week, Vaccine, Pharmaceutical industry, Cosmetics, TRuE-V, Ruxolitinib Cream, Incyte Dermatology, Incyte, TRUE-V, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

Incyte (Nasdaq:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.
  • In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data.
  • Ruxolitinib cream is an investigational novel cream formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib.
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

Retrieved on: 
Tuesday, September 21, 2021
Biotechnology, Pharmaceutical, Health, Food, Research, Contact dermatitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, JAK, Inflammation, George Washington University School of Medicine & Health Sciences, FDA, IGA, Patient, Outline of health sciences, AD, Atopic dermatitis, Itch, Associate, Disease, BID, Safety, Skin, Pharmaceutical industry, TRuE-AD, Opzelura, Incyte Dermatology, Incyte, TRUE-AD, OPZELURA, INCYTE DERMATOLOGY, INCYTE

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

Key Points: 
  • Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.
  • Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD.
  • The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress

Retrieved on: 
Monday, September 13, 2021
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Cream, AD, U.S. Securities and Exchange Commission, Security (finance), 2021 Essex County Council election, Knowledge, FDA, Safety, Inflammation, Adolescence, Marketing, Company, Hidradenitis suppurativa, Journal of the European Academy of Dermatology and Venereology, Annual report, Adult, Ageing, Therapy, Abstract, JAK, Skin, Solution, Atopic dermatitis, COVID-19, Autoimmunity, Medical history, European Academy of Allergy and Clinical Immunology, Research, Treatment, Congress, Pharmaceutical industry, Vaccine, Cosmetics, Ruxolitinib Cream, Incyte Dermatology, Incyte, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

These data from the Phase 3 TRuE-V program underscore our commitment to bringing new therapies to patients with challenging skin diseases.

Key Points: 
  • These data from the Phase 3 TRuE-V program underscore our commitment to bringing new therapies to patients with challenging skin diseases.
  • Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3 Studies (Abstract #D3T01.2A.
  • Session: Atopic dermatitis/Eczema)
    Efficacy of Ruxolitinib Cream among Patients with Atopic Dermatitis Based on Previous Medication History (encore) (Abstract #P0192.
  • Ruxolitinib cream is a proprietary formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.

Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference

Retrieved on: 
Saturday, June 12, 2021
Health, FDA, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Pyrazoles, Atopic dermatitis, Type I hypersensitivity, Ruxolitinib, Incyte, Janus kinase inhibitor, Tofacitinib, Ruxolitinib Cream, Incyte Dermatology, Incyte, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.
  • We are pleased to be sharing new data from our Phase 3 TRuE-AD program at the RAD Virtual Conference.
  • These data provide additional insights on the potential role ruxolitinib cream could play as a treatment option for patients living with atopic dermatitis.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

Incyte Announces Data on Ruxolitinib Cream in Atopic Dermatitis Accepted for Presentation at the Society for Investigative Dermatology (SID) Virtual Meeting 2021

Retrieved on: 
Monday, May 3, 2021
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Type I hypersensitivity, Autoimmune diseases, Medical specialties, Immunology, Atopic dermatitis, Dermatitis, Atopy, Clinical medicine, Janus kinase inhibitor, Ruxolitinib Cream, Incyte Dermatology, Incyte, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

Patient Population Research)\nRuxolitinib Cream Rapidly Decreases Skin Pain in Atopic Dermatitis (Abstract #325.

Key Points: 
  • Patient Population Research)\nRuxolitinib Cream Rapidly Decreases Skin Pain in Atopic Dermatitis (Abstract #325.
  • Patient Population Research)\nItch-Free State in Patients with Atopic Dermatitis Treated with Ruxolitinib Cream (Abstract #313.
  • Patient Population Research)\nEfficacy of Ruxolitinib Cream in Adults and Adolescents with Atopic Comorbidities (Abstract #329.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).

Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis

Retrieved on: 
Friday, April 23, 2021
Biotechnology, Health, Science, Pharmaceutical, Research, Chemical compounds, Type I hypersensitivity, Organic compounds, Medical specialties, Autoimmune diseases, Atopic dermatitis, Ruxolitinib, SCORAD, Dermatitis, Atopy, Janus kinase inhibitor, Atopic Dermatitis, TRuE-AD, Ruxolitinib Cream, Incyte Dermatology, Incyte, ATOPIC DERMATITIS, TRUE-AD, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

b'Incyte (Nasdaq:INCY) today announced findings from three pooled analyses of its randomized, double-blind, vehicle-controlled Phase 3 studies \xe2\x80\x93 TRuE-AD1 and TRuE-AD2 \xe2\x80\x93 evaluating ruxolitinib cream, an investigational JAK1/JAK2 inhibitor designed for topical application, as a treatment for patients with atopic dermatitis (AD).

Key Points: 
  • b'Incyte (Nasdaq:INCY) today announced findings from three pooled analyses of its randomized, double-blind, vehicle-controlled Phase 3 studies \xe2\x80\x93 TRuE-AD1 and TRuE-AD2 \xe2\x80\x93 evaluating ruxolitinib cream, an investigational JAK1/JAK2 inhibitor designed for topical application, as a treatment for patients with atopic dermatitis (AD).
  • Additional secondary endpoints include mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).
  • The Company disclaims any intent or obligation to update these forward-looking statements.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210423005325/en/\n'

Multiple Abstracts from Incyte’s Dermatology Portfolio Accepted for Presentation at the AAD Virtual Meeting Experience

Retrieved on: 
Tuesday, April 20, 2021
Biotechnology, Pharmaceutical, Health, Environment, Chemical compounds, Type I hypersensitivity, Organic compounds, Autoimmune diseases, Atopic dermatitis, Ruxolitinib, Atopy, Dermatitis, Incyte, Ruxolitinib Cream, Incyte Dermatology, Incyte, RUXOLITINIB CREAM, INCYTE DERMATOLOGY, INCYTE

ET), and can be accessed until July 12, 2021.

Key Points: 
  • ET), and can be accessed until July 12, 2021.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.\nIncyte\xe2\x80\x99s science-first approach and expertise in immunology has formed the foundation of the company.
  • The Company disclaims any intent or obligation to update these forward-looking statements.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210420005436/en/\n'