TRUE-V

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 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.