Ruxolitinib Cream

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

Retrieved on:

Thursday, October 28, 2021

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

Retrieved on:

Monday, September 13, 2021

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

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

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

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'

Pooled Results from Incyte’s TRuE-AD1 and TRuE-AD2 Atopic Dermatitis Studies of Ruxolitinib Cream Show Clinically Meaningful Improvements in Patient-Reported Quality of Life Assessments

Retrieved on:

Thursday, October 29, 2020

The overall safety profile of ruxolitinib cream was consistent with previously reported data, with no new safety signals observed in this pooled analysis.

Key Points:

The overall safety profile of ruxolitinib cream was consistent with previously reported data, with no new safety signals observed in this pooled analysis.
Atopic dermatitis (AD) is a common chronic and intensely pruritic disease characterized by inflammation of the skin.
The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
Ruxolitinib cream is a proprietary formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.

Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

Retrieved on:

Wednesday, February 19, 2020

The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age 12 years) with mild-to-moderate atopic dermatitis (AD).

Key Points:

The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age 12 years) with mild-to-moderate atopic dermatitis (AD).
Key efficacy results include:
50.0% of patients treated with ruxolitinib cream 0.75% BID and 53.8% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 15.1% treated with vehicle control (p
39.0% of patients treated with ruxolitinib cream 0.75% BID and 51.3% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 7.6% treated with vehicle control (p
The TRuE-AD clinical trial program consists of two randomized, double-blind, dose-ranging, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD).

Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis

Retrieved on:

Tuesday, January 28, 2020

The study, part of the TRuE-AD clinical trial program, met its primary endpoint.

Key Points:

The study, part of the TRuE-AD clinical trial program, met its primary endpoint.
The overall efficacy and safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed.
TRuE-AD2 (NCT03745651) is an Incyte-sponsored randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD).
The TRuE-AD clinical trial program is evaluating ruxolitinib cream in patients with atopic dermatitis (AD) and includes two Phase 3 studies: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651).

Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo

Retrieved on:

Saturday, October 12, 2019

Incyte (Nasdaq:INCY) today announces positive 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo.

Key Points:

Incyte (Nasdaq:INCY) today announces positive 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo.
As we seek to offer a much-needed option for those patients impacted by this life-altering disease, we are excited that the pivotal Phase 3 studies evaluating ruxolitinib cream in patients with vitiligo are underway, with results expected in 2021.
Among all patients treated with 1.5 percent ruxolitinib cream BID, the proportion of patients achieving T-VASI50 at Week 52 was 36.4 percent.
The safety and efficacy of ruxolitinib cream are being evaluated in an Incyte-sponsored randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2 study (NCT03099304), which began in April 2017.