Retrieved on:
Wednesday, October 11, 2023
Biotechnology,
Other Health,
Health,
Pharmaceutical,
Clinical Trials,
Congress,
Journal of the European Academy of Dermatology and Venereology,
Autoimmunity,
Vitiligo,
BID,
Abstract,
Ciclosporin,
Inflammation,
Depigmentation,
Prevalence,
Azathioprine,
Pigmentation disorder,
Melanocyte,
American Academy,
Week,
University,
JAK,
AAD,
Netherlands,
Skin,
LTE,
Patient,
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Dermatology,
Venereology,
Incyte These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.
Key Points:
- These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.
- Opzelura is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
- The overall prevalence of the condition is estimated to be approximately 2-3 million2, with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo3.
- Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304.
Biotechnology,
Pharmaceutical,
Health,
Clinical Trials,
Inflammation,
Week,
The New England Journal of Medicine,
Autoimmunity,
American Academy,
Depigmentation,
Patient,
AAD,
BID,
American Academy of Dermatology,
Vitiligo,
LTE,
Skin,
Safety,
Pharmaceutical industry The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
Key Points:
- The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
- “The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
- Approximately 29% of patients randomized to the withdrawal arm (i.e., applying vehicle cream) relapsed (
- “Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”
Retrieved on:
Friday, February 24, 2023
Biotechnology,
Pharmaceutical,
Health,
CHMP,
Headache,
Safety,
Dermatology,
Civil service commission,
The New England Journal of Medicine,
News,
Week,
European,
Committee,
Urinary tract infection,
European Medicines Agency,
Vitiligo,
Patient,
Committee for Medicinal Products for Human Use,
EMA,
Acne,
Common,
Committee on Herbal Medicinal Products,
European Commission,
Professor,
Incidence,
Pharmaceutical industry,
EU Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Key Points:
- Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
- “The positive CHMP opinion brings us one step closer to bringing ruxolitinib cream, the first ever treatment for repigmentation in non-segmental vitiligo, to patients and healthcare professionals in the European Union (EU),” said Steven Stein, M.D., Chief Medical Officer, Chief Medical Officer, Incyte.
- The CHMP’s opinion is now being reviewed by the European Commission, which has the authority to grant centralized marketing authorizations for medicinal products in the EU.
- When approved, this will be the first approved vitiligo therapy available in the EU indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Retrieved on:
Wednesday, October 19, 2022
Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.
Key Points:
- Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.
- Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 306.
- The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 ( NCT04052425 ) and TRuE-V2 ( NCT04057573 ), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.
- Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.
Key Points:
- Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.
- Vitiligo can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 305.
- There have been no FDA-approved therapies available to date and the approval of Opzelura therefore marks a significant milestone.
- Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
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.
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.
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,
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Melanocyte,
EMA,
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Congress,
Body surface area,
VNS,
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Solution,
Classification,
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BSA,
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Week,
Vaccine,
Pharmaceutical industry,
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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.
Retrieved on:
Wednesday, September 25, 2019
Biotechnology,
Pharmaceutical,
FDA,
Health,
Genetics,
Clinical trials,
Chemical compounds,
Health,
Organic compounds,
Pyrazoles,
Nitriles,
Cyclopentanes,
Ruxolitinib,
Vitiligo,
Incyte,
Clinical trial,
TRuE-V,
Ruxolitinib Cream,
Incyte Incyte (Nasdaq:INCY) today announced that the first patient has been treated in the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream as a monotherapy for adolescent and adult patients (age 12 years) with vitiligo.
Key Points:
- Incyte (Nasdaq:INCY) today announced that the first patient has been treated in the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream as a monotherapy for adolescent and adult patients (age 12 years) with vitiligo.
- The initiation of the global Phase 3 TRuE-V clinical trial program is an important milestone as we seek to provide a treatment option that offers meaningful improvements for vitiligo patients.
- It can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 202.
- The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.
