Associated tags: Therapy, Patient, Pharmaceutical industry, Health, Pharmaceutical, Biotechnology, Clinical Trials, Research, Safety, Incyte, Week
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Safety Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS).
Key Points:
- Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS).
- Treatment-emergent adverse events (TEAEs) occurred in 38.2% of patients who applied ruxolitinib cream 1.5% versus 42.9% of patients who applied vehicle control.
- The most common TEAEs among patients receiving ruxolitinib cream 1.5% were COVID-19 (5.9%) and nasopharyngitis (5.9%).
- Discontinuation due to TEAEs were infrequent (ruxolitinib cream 1.5%, n=2 [5.9%]; vehicle control, n=0 [0%]), and no serious TEAEs were reported in the ruxolitinib cream 1.5% group.
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Incyte and WILMINGTON, Del., July 24, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) and Incyte (Nasdaq: INCY) today announced positive topline data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy.
Key Points:
- and WILMINGTON, Del., July 24, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) and Incyte (Nasdaq: INCY) today announced positive topline data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy.
- Based on these results, and pending agreement from the U.S. Food and Drug Administration (FDA), Syndax and Incyte intend to submit a Biologics License Application (BLA) to the FDA by year-end 2023.
- "Today marks an important day not only for Syndax and Incyte, but, more importantly, for patients suffering from chronic GVHD," said Michael A. Metzger, Chief Executive Officer of Syndax.
- These results underscore our belief that axatilimab could provide a valuable and highly differentiated therapeutic option for this devastating disease.
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Pharmaceutical industry Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
Key Points:
- Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
- Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores.
- “Vitiligo is a chronic, immune-mediated disease which, until recently, had limited treatment options available to patients.
- “As vitiligo can impact patients in different ways, I am encouraged by the continued focus on expanding medical treatment options, and I believe these data highlight the potential of this investigational oral treatment for patients with extensive nonsegmental vitiligo.”
Biotechnology,
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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.”
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Pemigatinib Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.
Key Points:
- Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.
- ET)
Five-Year Safety and Efficacy of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study1(Abstract #CT022.
- ET)
For registered attendees, the virtual meeting platform and all on-demand sessions will be available through July 19, 2023.
- More information regarding the AACR Annual Meeting 2023 can be found at https://www.aacr.org/meeting/aacr-annual-meeting-2023/ .
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Medical imaging IRVING, Texas, March 7, 2023 /PRNewswire/ -- Caris Life Sciences ®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline.
Key Points:
- IRVING, Texas, March 7, 2023 /PRNewswire/ -- Caris Life Sciences ®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline.
- "This partnership with Incyte will leverage Caris' leading molecular science and technology solutions to support Incyte's oncology research and development efforts," said David Spetzler , M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences.
- Incyte will also leverage Caris' biomarker-driven patient selection for clinical trials including options to partner on developing companion diagnostics for programs in the partnership.
- "Our partnership with Caris will bring a comprehensive suite of precision medicine capabilities to augment Incyte's success in developing key programs in our robust oncology portfolio."
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Friday, February 24, 2023
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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.
We look forward to working with the FDA to further explore baricitinib's potential to become the first approved treatment option for these individuals."
Key Points:
- We look forward to working with the FDA to further explore baricitinib's potential to become the first approved treatment option for these individuals."
- The FDA Breakthrough Therapy designation is based on the positive Phase 2 results of Lilly's adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib versus placebo in adult patients with AA.
- Baricitinib is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
- SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death.
Retrieved on:
Thursday, December 13, 2018
Medicine,
Anatomy,
Autoimmune diseases,
RTT,
Health,
Connective tissue diseases,
Rheumatology,
Cutaneous lupus erythematosus,
Systemic lupus erythematosus,
Autoimmunity,
Lupus erythematosus,
Rheumatoid arthritis "As part of the Fast Track designation, we will work closely with the FDA to further explore baricitinib's potential as a treatment that can provide meaningful improvements for people with SLE."
Key Points:
- "As part of the Fast Track designation, we will work closely with the FDA to further explore baricitinib's potential as a treatment that can provide meaningful improvements for people with SLE."
- Baricitinib is approved in over 50 countries globally as OLUMIANT for the treatment of adults with rheumatoid arthritis.
- Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
- Systemic lupus erythematosus (SLE) is a chronic, multi-organ autoimmune disease that can cause widespread tissue and organ damage.
