Janus kinase 1

Dizal Highlights Its Advances in Hematological Portfolio at 2023 ASH, Featuring Breakthroughs in Lymphoma Treatment

Retrieved on: 
Friday, November 3, 2023

Golidocitinib is the first and only Janus kinase 1 (JAK1) selective inhibitor in the NDA stage for the treatment of r/r PTCL.

Key Points: 
  • Golidocitinib is the first and only Janus kinase 1 (JAK1) selective inhibitor in the NDA stage for the treatment of r/r PTCL.
  • Golidocitinib monotherapy demonstrated superior efficacy and safety profile in the full analysis of the JACKPOT8 PARTB study, which was consistent with the preliminary findings presented at 2023 ASCO.
  • The pooled analysis results from these two studies will be presented for the first time at 2023 ASH.
  • Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8)

Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders

Retrieved on: 
Wednesday, March 22, 2023

Brain penetrant inhibitors of TYK2/JAK1 have the potential to bring this validated immune target to brain disorders.

Key Points: 
  • Brain penetrant inhibitors of TYK2/JAK1 have the potential to bring this validated immune target to brain disorders.
  • There are currently no brain penetrant, selective, dual TYK2/JAK1 inhibitors approved for brain disorders.
  • We have delivered what we believe is a best-in-class dual TYK2/JAK1 molecule and the team at Biohaven has the clinical development expertise to explore its utility in brain disorders.
  • We are excited to work with Chris and the team at Highlightll to advance this novel and highly differentiated dual TYK2/JAK1 inhibitor in the treatment of brain disorders."

CMS (867.HK) Joins Hand with Incyte on Ruxolitinib Cream, Brings 1st Repigmentation Drug for Vitiligo Patient

Retrieved on: 
Tuesday, December 6, 2022

Ruxolitinib Cream is the only topical JAK inhibitor and the first vitiligo repigmentation drug approved by the U.S. FDA.

Key Points: 
  • Ruxolitinib Cream is the only topical JAK inhibitor and the first vitiligo repigmentation drug approved by the U.S. FDA.
  • Through this transaction, CMS once again brings a novel treatment option for patients with unmet medical needs.
  • The product was approved by the FDA in July 2022 for the topical non-segmental vitiligo patients.
  • In July this year, Ruxolitinib Cream became the first and only drug approved by the U.S. FDA for vitiligo patients repigmentation.

Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255

Retrieved on: 
Monday, December 5, 2022

“Alopecia areata is an immune condition that not only causes hair loss, but also causes significant negative impact on an individual’s emotional and mental wellbeing.

Key Points: 
  • “Alopecia areata is an immune condition that not only causes hair loss, but also causes significant negative impact on an individual’s emotional and mental wellbeing.
  • Today, there are no FDA-approved topical therapies to treat the condition,” said Frank Watanabe, President and CEO at Arcutis.
  • ARQ-255, or topical invarmactiniib suspension, is a topical janus kinase 1 (JAK1) inhibitor therapy for alopecia areata.
  • Topical treatment of alopecia areata is challenging due to the depth of inflammation and the dense vasculature that surrounds the hair bulb.

TYK2 Kinase Inhibitors - Pipeline Insight 2022: Key Players Include Bristol-Myers Squibb, Oncostellae, Pfizer and Galapagos - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 22, 2022

The "TYK2 kinase inhibitors - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "TYK2 kinase inhibitors - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • It further highlights the inactive pipeline products in this space
    Tyrosine kinase 2 (Tyk2) is a non-receptor tyrosine-protein kinase, an enzyme that in humans is encoded by the TYK2 gene.
  • The companies and academics are working to assess challenges and seek opportunities that could influence TYK2 Kinase Inhibitors R&D.
  • TYK2 Kinase Inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, January 14, 2022

Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin.

Key Points: 
  • Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin.
  • We appreciate Pfizers commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis.
  • Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the New Drug Application (NDA) to support the FDA approval.
  • Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population.

European Commission Approves Pfizer’s Cibinqo® (abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, December 10, 2021

Cibinqo also demonstrated a consistent safety profile across trials, including in a long-term extension study, showing a favorable benefit-risk profile.

Key Points: 
  • Cibinqo also demonstrated a consistent safety profile across trials, including in a long-term extension study, showing a favorable benefit-risk profile.
  • Findings from the following five studies in the Cibinqo JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the submission to support this approval.
  • The study also included an active control arm with dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
  • ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children.

Japan’s MHLW Approves Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Retrieved on: 
Thursday, September 30, 2021

Our priority will now be to ensure CIBINQO is routinely accessible to as many patients as possible.

Key Points: 
  • Our priority will now be to ensure CIBINQO is routinely accessible to as many patients as possible.
  • The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Great Britain marketing authorization for CIBINQO earlier this month.
  • Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
  • 2015;66(suppl 1):8-16.
    v Muto T, Hsieh SD, Sakurai Y, Yoshinaga H, Suto H, Okumura K, Ogawa H. Prevalence of atopic dermatitis in Japanese adults.

UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Retrieved on: 
Thursday, September 9, 2021

We welcome the MHRAs authorization of abrocitinib to treat people with moderate to severe atopic dermatitis.

Key Points: 
  • We welcome the MHRAs authorization of abrocitinib to treat people with moderate to severe atopic dermatitis.
  • Last year, abrocitinib received a Promising Innovative Medicine (PIM) designation from the MHRA.
  • This enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need.
  • Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis.

Arcutis Announces Second Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 5, 2021

The significant progress made at Arcutis in the first half of 2021 positions us well for an exciting next 18 months.

Key Points: 
  • The significant progress made at Arcutis in the first half of 2021 positions us well for an exciting next 18 months.
  • Arcutis anticipates submitting an NDA for plaque psoriasis to the U.S. Food and Drug Administration (FDA) late in the third quarter or early in the fourth quarter of 2021, based on the positive results from two pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2).
  • In July, Arcutis announced the initiation of a single pivotal Phase 3 trial for the treatment of seborrheic dermatitis, with topline data anticipated in the second or third quarter of 2022.
  • General and administrative (G&A) expenses for the quarter ended June30, 2021 were $11.3 million compared to $5.6 million for the corresponding period in 2020.