Dupilumab

Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 26, 2022
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Detailed results from a Phase 3 trial showed that adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-nave patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting.

Key Points: 
  • Detailed results from a Phase 3 trial showed that adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-nave patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting.
  • These results will be presented today in a late-breaking session at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
  • Data presented at AAAAI 2022 showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (referred to as placebo) with continuous improvement out to 24 weeks.
  • CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin.

Late-breaking Data at 2022 AAAAI Annual Meeting Show Dupixent® (dupilumab) Significantly Improved Signs and Symptoms of Eosinophilic Esophagitis

Retrieved on: 
Saturday, February 26, 2022
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These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session.

Key Points: 
  • These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session.
  • Data presented at the 2022 AAAAI Annual Meeting showed that patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo:
    64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008).
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.
  • In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE.

Positive Dupixent® (dupilumab) Data Across Five Diseases with Underlying Type 2 Inflammation to be Presented at 2022 AAAAI Annual Meeting

Retrieved on: 
Tuesday, February 1, 2022
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The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis.

Key Points: 
  • The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis.
  • These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations.
  • IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.
  • To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Second positive Phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis

Retrieved on: 
Wednesday, January 19, 2022
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People with prurigo nodularis can experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.

Key Points: 
  • People with prurigo nodularis can experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.
  • Nearly three times as many Dupixent patients achieved clear or almost clear skin, a secondary endpoint: 48% of Dupixent patients compared to 18% of placebo patients (p= 0.0004).
  • Dupixent patients experienced significantly greater improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression.
  • Additionally, 0% of Dupixent patients and 4% of placebo patients discontinued treatment due to adverse events prior to week 24.

Analysis Group Researchers Demonstrate a Highly Effective New Real-World Data Generation Method

Retrieved on: 
Wednesday, January 19, 2022
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BOSTON, Jan. 19, 2022 /PRNewswire/ -- Analysis Group , a global leader in health economics and outcomes research (HEOR), announced that its groundbreaking method for generating real-world data (RWD) has proven both effective and repeatable.

Key Points: 
  • BOSTON, Jan. 19, 2022 /PRNewswire/ -- Analysis Group , a global leader in health economics and outcomes research (HEOR), announced that its groundbreaking method for generating real-world data (RWD) has proven both effective and repeatable.
  • Groundbreaking method for generating real-world data used in study published by JAMA Dermatology.
  • "Faster access to reliable data from the clinical setting canenhance clinicians' effective management of diseases with newer treatments."
  • "Data sources are the biggest challenge for early real-world evidence generation post-product launch," explained study investigator Min Yang , M.D., Ph.D., a Vice President with Analysis Group.

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

Retrieved on: 
Friday, January 14, 2022
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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
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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.

Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease

Retrieved on: 
Monday, October 25, 2021
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EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

Key Points: 
  • EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
  • The current standard of care for people with eosinophilic esophagitis may only provide limited relief of their symptoms.
  • We look forward to continuing to study Dupixents potential role in addressing the underlying type 2 inflammation that can lead to eosinophilic esophagitis.
  • The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with eosinophilic esophagitis.

Global Atopic Dermatitis Drugs Market 2021-2026 by Drug Class, Route of Administration, Geography, Competitive Analysis - ResearchAndMarkets.com

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Friday, August 20, 2021
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The Global Atopic Dermatitis Drugs Market is estimated to be USD 7.2 Bn in 2021 and is expected to reach USD 10 Bn by 2026, growing at a CAGR of 6.8%.

Key Points: 
  • The Global Atopic Dermatitis Drugs Market is estimated to be USD 7.2 Bn in 2021 and is expected to reach USD 10 Bn by 2026, growing at a CAGR of 6.8%.
  • The major factor driving the growth of the global atopic dermatitis drugs market is the growing incidence of food allergies exacerbating atopic dermatitis, increasing emphasis on systematic therapies, increasing pharmacological products in developing countries, and the rise in awareness regarding the availability of treatments for the disease.
  • Furthermore, the rising adoption of targeted treatments such as Eucrisa and Dupixent is propelling the market.
  • By Drug Class, the market is classified into biologics, calcineurin inhibitors, corticosteroids, and pde4 inhibitors.

Phase 3 trial of Libtayo® (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer

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Thursday, August 5, 2021
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This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended.

Key Points: 
  • This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended.
  • Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions.
  • Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  • Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( http://newsroom.regeneron.com ) and its Twitter feed ( http://twitter.com/regeneron ).